Most recent reports appear first

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter
Than Expected

Some battery modules distributed after Jan. 31, 2010 have a shorter
battery run time than expected. This can result in unexpected ventilator shut downs,
which can result in serious adverse health consequences, including death. This
recall covers 90,000 battery modules distributed in the United States between
02/15/2010 and 11/19/2012.

Battery modules allow device users a possibility to operate the
SERVO-i ventilator during intra-hospital transportation. The SERVO-i system is used
to treat and monitor patients ranging from neonates to adults with respiratory
failure or insufficiency.

Customers are instructed to change the power source to AC and
replace the battery modules if either “low battery voltage” or “replace battery”
messages are displayed. Customers are instructed to complete and return a Field
Safety Notice Confirmation Form via fax at (973) 807-1832.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa
Dystonia HDE Kit

Medtronic sent an Urgent Medical Device Correction letter to all affected
customers notifying them of the potential for damage due to the use of the lead cap
provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being
damaged at the connector end of the lead when the lead cap is used. The connector
end of the lead is the end of the lead connected to the lead extension. Tightening
or loosening of the setscrew may twist the setscrew connector block and may damage
the proximal connector end of the lead. If this happens, the damage would most
likely occur at lead contact #3 which could affect electrode contact #3.Depending on
the extent of lead damage and the need to use electrode #3, lead replacement may be
required or optimal therapy may not be provided.

This recall covers 1,598 devices distributed in the United States between 04/2006
and 02/28/2013. Refer to the Recall Notice for a list of affected models. 

The deep brain stimulation (DBS) system delivers electrical
stimulation to selected targets in the brain. DBS leads are indicated for Dystonia,
Essential Tremor, Obsessive-Compulsive Disorder, Parkinson’s disease, and epilepsy.
Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the
internal globus pallidus or the subthalamic nucleus to aid in the management of
chronic, intractable (drug refractory) primary dystonia including generalized and/or
segmental dystonia, hemidystonia and cervical dystonia (torticollis).

If the lead cap is used during the implant procedure, customers
should follow modified instructions (refer to the Urgent Medical Device Correction
letter for details). For questions call Medtronic Neuromodulation Technical Services
1-800-707-0933. The firm is providing additional instructions for capping the lead
and removing the lead cap and is not removing the product from market. There is no
action required for existing patients in the absence of concern over potential lead
damage.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before
They Were Sterilized

Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with lot
number N3B0165LX were stolen from the manufacturer before they were sterilized.
Although these devices were packaged and labeled as sterile, they are not sterile.
The FDA is aware that some of these stolen and unsterile products have been offered
for sale. The use of these non-sterile products could increase the risk of infection
in surgical patients. The FDA Office of Criminal Investigation is in contact with
Covidien regarding this situation.

The Covidien surgical stapler reloads are used in abdominal,
gynecologic, pediatric and thoracic surgery.
 
The only way to identify the stolen, unsterile products is to
check the Reference Code and the Lot Number on every box of Covidien Surgical
Stapler Reloads prior to use. Do not use Covidien Endo GIA Articulating 60-3.5
Surgical Stapler Reloads labeled with Reference Code 030458 and Lot number
N3B0165LX. 

Check your current inventory to determine if you have the surgical stapler reloads
with lot number N3B0165LX. If you have these products, quarantine them and contact
Covidien at 1-800-522-0263, option 5, for more information. Purchase products from
trusted and reliable sources such as the manufacturer or authorized distributors, do
not purchase these products from online auction sites. Contact the FDA Office of
Criminal Investigation at 1-800-551-3989 if
you have any information regarding these stolen devices.  

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Cardinal Health: Class 1 Recall - Various Presource Kits Containing a Pre-Assembled
Anesthesia Circuit

*ISSUE*: Cardinal Health discovered that various Presource Kits containing a
pre-assembled anesthesia circuit and filter may contain outer plastic packaging on
one or more components. If the packaging is removed without dissembling the
components, remnants of the plastic from the packaging material may become lodged in
the filter potentially causing an obstruction in airflow. This may result in serious
adverse health consequences including low blood oxygen (hypoxia), suffocation and
death.

Cardinal Health’s pre-assembled Filter and Anesthesia Circuit are
intended to provide respiratory support to deliver oxygen, air, and nitrous oxide in
a controlled manner to a patient. These assemblies are included in various Presource
convenience kits including, but not limited to, gynecology laparoscopy kits, general
laparoscopy kits, knee arthroscopy kits, and total hip kits.

Cardinal Health notified customers of the problem and products
affected (refer to the Recall Notice for a full list of affected products).
Customers should examine their inventories, identify and locate the products
affected, notify clinicians, and affix a WARNING LABEL on the front of each kit. The
WARNING LABEL instructs clinicians to remove and discard the anesthesia circuit and
filter assembly. Customers are also asked to confirm receipt of the notification
letter and completion of the labeling activity by returning an Acknowledgement Form.
If customers are not comfortable with adding the WARNING LABEL to the kits or using
these kits, they should contact Cardinal Health at 1-800-766-0706 for further
instructions.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for
Pregnant Women for Prevention of Migraine Headaches

Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and
Depakote ER), valproic acid (Depakene and Stavzor), and their generics*

FDA is advising health care professionals and women that the anti-seizure
medication valproate sodium and related products, valproic acid and divalproex
sodium, are contraindicated and should not be taken by pregnant women for the
prevention of migraine headaches. Based on information from a recent study, there is
evidence that these medications can cause decreased IQ scores in children whose
mothers took them while pregnant. Stronger warnings about use during pregnancy will
be added to the drug labels, and valproate’s pregnancy category for migraine use
will be changed from "D" (the potential benefit of the drug in pregnant women may be
acceptable despite its potential risks) to "X" (the risk of use in pregnant women
clearly outweighs any possible benefit of the drug).

Valproate products will remain in pregnancy category D for treating epilepsy and
manic episodes associated with bipolar disorder.

Valproate products are approved for the treatment of certain types of
epilepsy, the treatment of manic episodes associated with bipolar disorder, and the
prevention of migraine headaches. They are also used off-label (for uses not
approved by FDA) for other conditions, particularly other psychiatric conditions.

This alert is based on the final results of the Neurodevelopmental Effects of
Antiepileptic Drugs (NEAD) study showing that children exposed to valproate products
while their mothers were pregnant had decreased IQs at age 6 compared to children
exposed to other anti-epileptic drugs. For additional details, see the Drug Safety
Communication Data Summary section.

Valproate products should not be used in pregnant women for
prevention of migraine headaches and should be used in pregnant women with epilepsy
or bipolar disorder only if other treatments have failed to provide adequate symptom
control or are otherwise unacceptable. 

Women who are pregnant and taking a valproate medication should not stop their
medication but should talk to their health care professionals immediately. Stopping
valproate treatment suddenly can cause serious and life-threatening medical problems
to the woman or her baby.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential
Medication Errors Resulting from Name Confusion

The FDA notified health care professionals that the use of the incorrect
nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine)
in some medication-related electronic systems poses a risk of mix-up with Herceptin
(trastuzumab) and may result in medication errors. The dosing and treatment
schedules for Kadcyla and Herceptin, another breast cancer drug, are quite
different, so confusion between these products could lead to dosing errors and
potential harm to patients.

The FDA-approved nonproprietary name for Kadcyla, ado-trastuzumab emtansine, should
be used. However, some third-party publications, compendia references, health
information systems (e.g., electronic health record systems and systems used for
pharmacy prescription processing, wholesaler ordering, pharmacy ordering, etc.), and
sites on the Internet are incorrectly using the United States Adopted Name (USAN),
which is “trastuzumab emtansine,” and omitting the “ado” prefix and hyphen. Use of
this truncated version of Kadcyla’s nonproprietary name may cause confusion with
Herceptin (trastuzumab).

It is important for drug information content publishers to identify drug products by
the FDA-approved proprietary (brand) and nonproprietary names that are used in
FDA-approved drug labels. This will help prevent medication errors and ensure
adverse events are reported for the correct product.

No medication errors related to confusion between Kadcyla and Herceptin have been
reported to FDA since approval of Kadcyla on February 22, 2013; however medication
errors did occur during the clinical trials that evaluated its safety and efficacy
prior to approval.

Kadcyla is used to treat HER2-positive breast cancer that has spread
to other parts of the body in patients who have received prior treatment with
Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is made up of
trastuzumab, an anti-HER2 therapy, connected to a drug called DM1 that interferes
with cancer cell growth.

Health care professionals should use both the FDA-approved
proprietary (brand) name Kadcyla and its nonproprietary name (ado-trastuzumab
emtansine) when communicating medication orders, on preprinted order sets, and in
computerized order entry systems. Such redundancy may help to reduce the potential
for medication errors. Additionally, strategies should be employed to warn against
confusion between Kadcyla (ado-trastuzumab emtansine) and Herceptin (trastuzumab) in
medication-related computer systems.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall -
Unit Goes Into Internal Backup Battery Sooner Than Expected*

The recall is in response to customer reports of Newport Medical
Instrument’s HT70 Ventilator and HT70 Plus Ventilator alarming and going into
internal backup battery sooner than expected, while the ventilator is being operated
on Power Pac battery. Serial number range: 2096134110001 to 2292048120050, Rev. C
through Rev. F These ventilators were manufactured from Nov. 1, 2009 to March 5,
2013 and distributed from Oct. 1, 2011 to Jan. 31, 2013.

These conditions have been reported in two types of situations. In the first
situation, the screen on the Newport Medical Instrument’s HT70 Ventilator or HT70
Plus Ventilator may indicate that the Power Pac battery is fully charged when it is
not. In the second situation, the unit may switch to backup battery power as soon as
it is removed from AC power.

Use of this device on battery power may cause serious adverse health consequences,
including death.

The HT70 and HT70 Plus ventilator systems are intended to provide
continuous or intermittent positive pressure mechanical ventilatory support for the
care of individuals who require mechanical ventilation.

Newport Medical Instruments, Inc. is a wholly-owned subsidiary of Covidien.

On April 4, 2013, Newport Medical Instruments sent an Urgent
Medical Device Recall letter by FedEx to all its affected customers. The letter
identified the product, the problem, and the action to be taken by the customer.

Anyone who has Power Pac batteries for the Newport Medical Instrument’s HT70 and
HT70 Plus ventilators, including distributors, health care providers, and home
users, is instructed to immediately check the serial numbers of the Power Pac
batteries related to their Newport HT70 and HT70 Plus ventilators. Customers whose
Power Pac serial numbers fall within the above range should contact Newport Medical
Instrument’s Technical Support Department to request replacement batteries, which
will be provided at no charge.

If customers are using the affected product, they should ensure that an alternate
source of power is available nearby until this issue is resolved. Customers were
also instructed to report any issues with Newport Medical Instrument’s HT70 and HT70
Plus ventilators or Power Pac batteries to the Technical Support group at
1-800-451-3111, extension 500 to ensure proper device reporting procedures are
followed.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By
Fenwal: Recall - Labeling Issue Identified

Fenwal has initiated a voluntary Urgent Product Recall of one lot
(FM13A15027) of product code 4R1584, Anticoagulant Citrate Phosphate Dextrose
Solution, USP (CPD) BLOOD-PACK unit.  Fenwal identified a labeling issue with this
batch of Product Code 4R1584 in which the platelet container is incorrectly labeled
as “AS-1 Red Blood Cell Adenine-Saline added”. 

To date, there is only one reported occurrence of this incident and no
safety concerns have been raised.

Fenwal is recommending that customers immediately check their
inventory, discontinue the use of this product, and return the impacted product to
Fenwal.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To
Possible Liver Injury Leading to Organ Transplant or Death

FDA has determined that the drug Samsca (tolvaptan) should not be used for
longer than 30 days and should not be used in patients with underlying liver disease
because it can cause liver injury, potentially leading to liver transplant or death.
FDA has worked with the manufacturer to revise the Samsca drug label to include new
limitations.

Samsca is a selective vasopression V2-receptor antagonist indicated
for the treatment of clinically significant hypervolemic and euvolemic hyponatremia,
including patients with heart failure and Syndrome of Inappropriate Antidiuretic
Hormone (SIADH). An increased risk of liver injury was observed in recent large
clinical trials evaluating Samsca for a new use in patients with autosomal dominant
polycystic kidney disease (ADPKD).

Samsca treatment should be stopped if the patient develops signs
of liver disease. Treatment duration should be limited to 30 days or less, and use
should be avoided in patients with underlying liver disease, including cirrhosis.
Patients should be aware that Samsca may cause liver problems, including
life-threatening liver failure, and should contact their health care professional to
discuss any questions or concerns about Samsca.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or
Crystallization in IV Bag or IV Line Upon Reconstitution

Apotex Corp. notified healthcare professionals it is conducting, on behalf
of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of
Piperacillin and Tazobactam for Injection, USP 40.5 grams, to the
hospital/healthcare provider/user level. The impacted lots may show precipitation/
crystallization in IV bag or IV line after reconstitution. The product can also be
identified by NDC number 60505-0773-00 and UPC 360505077304. The product was
distributed nationwide in the United States to wholesalers, distributors, HMOs, home
infusion and long term care service providers. See Press Release for a list of
affected lot numbers

Hospira stated that administration of precipitated Piperacillin/Tazobactam in an IV
bag or IV line may result in local reactions such as phlebitis, renal impairment,
end-organ embolism and ischemia, and/or vasculitis (because the precipitate was
visible, its particles may be large enough to cause these adverse events). In
addition, the precipitation of the drug may not allow delivering a needed
therapeutic dose of piperacillin and tazobactam, thus resulting in inadequate
treatment of the targeted infection. This could result in adverse health
consequences that could range from transient and minor impairment or complaints to
permanent impairment of a body function or permanent damage to a body structure.

Piperacillin and Tazobactam for Injection is indicated for the
treatment of patients with moderate to severe infections caused by
piperacillin-resistant, piperacillin/tazobactam-susceptable, ß-lactamase producing
strains of the designated microorganisms in the specified conditions such as,
Appendicitis, Uncomplicated and Complicated skin and skin structures infections,
Postpartum Endometritis or Pelvic Inflammatory disease, Community Acquired Pneumonia
and Nosocomial Pneumonia. The product is packaged in 300 mL glass vials for
reconstitution.

Anyone with an existing inventory of the product should stop use
and distribution, quarantine the recalled lots immediately and call GENCO at
1-877-674-2078 between the hours of 7 a.m. to 5 p.m. CST, Monday through Friday, to
arrange for their return.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage

Models 13000, 13100, 13150, 13086, 13087, 13088*

Hospira notified healthcare professionals of a Class I recall of the
GemStar Infusion System, Models 13000, 13100, 13150, 13086, 13087, 13088. When the
GemStar Lithium battery voltage level drops below 2.4 volts, an "11/004" error is
displayed and the device is rendered inoperable. This failure mode results in a
delay/interruption of therapy. Additionally, infusion settings and event history
logs will be erased as a result of this device malfunction.

The severity of the clinical impact, due to the delay/interruption in therapy, is
dependent upon the underlying condition of the patient and the treatment being
prescribed. A delay/interruption in therapy has a worst case potential to result in
a significant injury or death.

The affected units were manufactured and distributed between February 1999 and April
2013.

The GemStar Infusion System is a small, lightweight, single-channeled
device designed for use in the home, hospital or anywhere electronic infusion is
required. The device is intended for use in intravenous, arterial, subcutaneous,
short-term epidural infusion and parenteral administration of general I.V. fluids,
medications, nutritional foods and blood/blood products.

The customer notification letter stated that lithium batteries
that are older than three (3) years should be replaced. Contact the Hospira Advanced
Knowledge Center at 1-800-241-4002, option 4, 24 hours a day/7 days a week, to
determine if your battery needs to be replaced and if necessary to arrange for the
return of your device to perform battery replacement. Facilities that periodically
retrieve the history logs from their GemStar Infusion System should consider
retrieving them more often to reduce the amount of history log information that
would be lost should this failure occur.

Healthcare professionals are advised to weigh the risk/benefit to patients
associated with the use of the device when administering critical therapies.
Customers should consider the use of an alternative product, particularly in
patients in which a delay/interruption in therapy could result in significant injury
or death.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And
Blue Skin Discoloration

FDA is warning the public that the anti-seizure medication Potiga
(Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by
pigment changes in the retina. FDA does not currently know if these changes are
reversible. FDA is working with the manufacturer to gather and evaluate all
available information to better understand these events. FDA will update the public
when more information is available.

Potiga is approved as adjunctive (added on to other anti-seizure
medications) treatment of partial-onset seizures in adult patients 18 years and
older. The skin discoloration in the reported cases appeared as blue pigmentation,
predominantly on or around the lips or in the nail beds of the fingers or toes, but
more widespread involvement of the face and legs has also been reported. Scleral and
conjunctival discoloration, on the white of the eye and inside eyelids, has
been observed as well. The skin discoloration generally occurred after four years of
treatment with Potiga, but has appeared sooner in some patients. In some cases,
retinal abnormalities have been observed in the absence of skin discoloration.

All patients taking Potiga should have a baseline eye exam and
periodic eye exams that should include visual acuity testing and dilated fundus
photography, and may include fluorescein angiograms (FA), ocular coherence
tomography (OCT), perimetry, and electroretinograms (ERG). Patients who are taking
Potiga and develop any changes in your vision or any discoloration of your skin,
including of your lips and nail beds should contact their health care professional
right away. Patients should not stop taking Potiga without talking to their health
care professional.  Stopping such treatment suddenly can cause serious and
life-threatening medical problems such as recurrence of seizures.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Eba Multivitamin Supplement By Saratoga Therapeutics LLC: Recall - Allergy Alert On
Undeclared Milk Components

Saratoga Therapeutics, LLC of North Wales, PA recalled 900 bottles of ebA
Multivitamin Supplement because they may contain undeclared milk components – milk
protein(s) and lactose. The label lists the product as being free of milk
components. People with an allergy or severe sensitivity to milk run the risk of a
serious or life-threatening allergic reaction and people who have lactose
intolerance run the risk of gastrointestinal symptoms if they consume ebA
Multivitamin Supplement.

Affected lot numbers include #0912164 expiration date 12/12 and #1110354 expiration
date 10/14.

ebA Multivitamin Supplement was distributed nationwide and in
Australia, Canada, Costa Rica, England, Finland, Ireland, Malaysia, Switzerland, and
Tasmania. and reached consumers by mail order, fax order, internet sales and
doctors' office sales. The vitamins are packaged in a white plastic bottle with
white, green and blue labeling. The expiration date is listed beneath the Warning
section on the label.

Consumers who have purchased ebA Multivitamin Supplement may
return any unused portion of the product to Saratoga Therapeutics, LLC for a refund.
Contact the company at 215-661-9044 8:30 a.m. to 4:30
p.m. east coast time to request mailing materials and/or for any questions.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira:
Recall - Particulate Matter

Hospira notified the public that last August it initiated a voluntary
nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100
mL, Flexible Container, NDC 0409-7984-23. This action was due to one confirmed
customer report where four separate particulate issues were identified in four
individual flexible containers. The four single particles were identified as
follows: polyester fiber, nylon fiber, cotton fiber and nitrocellulose fiber,
respectively. Hospira is investigating to determine the root cause.

Affected lot number is 05-201-JT (the lot number may be followed by a -01). The
affected product has an expiration date of May 1, 2013, and was distributed within
the United States between May 2011 and August 2011 to wholesalers/distributors,
hospitals and pharmacies.

If solution containing particulate matter is used on a patient, this may result
acutely in local inflammation, phlebitis, and/or generalized low-level allergic
response to the particulate and/or embolize to other organs in the body.
Chronically, following sequestration, granulomatous formation in the lungs is
possible.

This product is used as a source of water and electrolytes. Product
was distributed within the following U.S. states: Alaska, Alabama, Arizona,
California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana,
Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri,
Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio,
Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia,
Washington, Wisconsin, West Virginia and Wyoming.

Anyone with an existing inventory should stop use and
distribution, quarantine the product immediately, and call Stericycle at
1-888-597-9582 between the hours of 8am to 5pm ET, Monday through Friday, to arrange
for the return of the product. Replacement product from other lots is available.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall - Device May
Randomly Delete Stored Information When Powered On

The Giraffe Incubator and Giraffe OmniBed may randomly delete stored
information and enter new information in its place (over-write) when the device
turns “on” or recovers from a power failure. When this occurs, the heater or oxygen
delivery option will turn “off” and the new set point will be “0”. In addition,
alarms may not appropriately alert users that heater or oxygen delivery options are
“off” or that the set points are less than intended. The alarm failure may go
unnoticed.

All newborn babies using this device are at risk of serious adverse health
consequences, including death, due to this malfunction. Inaccurate temperature can
result in hypothermia (dangerously low body temperature) or hyperthermia
(dangerously high body temperature), and inaccurate oxygen regulation can result in
hypoxia (low blood oxygen) or hyperoxia (high blood oxygen). In addition, newborn
babies requiring transport may be at increased risk of adverse health consequences
due to potential malfunction when moving from one power source to another (wall
outlet to/from battery power).

These products were manufactured and distributed from August 01, 2012 to December
01, 2012.

The Giraffe OmniBed can function as an incubator (closed mode) or as a
warmer (open mode) and can transition from one mode to the other on the user’s
demand. Incubators and warmers are used to maintain the body temperature of a
newborn baby. In “closed mode”, the OmniBed provides heat through a closed,
temperature-controlled environment. In “open mode”, the device provides heat in an
open environment using overhead heaters.

The Giraffe Incubator is an infant incubator used to maintain the body temperature
of a newborn baby by providing heat through a closed, temperature-controlled
environment. This device may include a controlled oxygen delivery system that is
used to provide stable amounts of oxygen to newborn babies.

On January 8, 2013, GE Healthcare sent "Urgent Medical Device
Correction" letters to affected customers notifying them of the problem, the
affected devices, and the action to be taken by the customer. In addition, customers
were given instructions for continued use of the Giraffe OmniBed and Giraffe
Incubators. GE Healthcare will correct all affected devices at no cost, and will
contact customers to arrange for this correction.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall: Failure to Provide a Warning at Extremely High Blood Glucose Levels

At extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch Verio IQ Meter will turn off instead of displaying the message “EXTREME
HIGH GLUCOSE above 600 mg/dL” as intended. When turned back on, the meter enters the “Set-Up” mode and requires the user to confirm the date and time settings before
being able to test again. However, if the glucose level is still measuring1024 mg/dL or above when testing, the meter will shut down again.

The OneTouch Verio IQ Blood Glucose Meter is an over-the counter single-use device intended to be used by a patient outside of a health care facility
as an aid to monitor the effectiveness of diabetes control measures sugar (glucose) in blood drawn from the fingertips. All OneTouch Verio IQ Blood Glucose Meters are
being recalled and were distributed from December 14, 2011 through March 7, 2013.

If the OneTouch Verio IQ Meter unexpectedly turns off and enters set-up mode after turning it back on, blood glucose may be extremely high, and you should call your
health care professional.  Call LifeScan Customer Service at 1-800-717-0276 for support. 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance

Nora Apothecary & Alternative Therapies announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached
the expiration date listed on the product. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility
assurance and were observed during a recent FDA inspection

The recall includes sterile products that Nora Apothecary & Alternative Therapies supplied to patients and offices of licensed medical
professionals.  Specifically, the recall includes approximately 95 dosage units of sterile compounded products that the pharmacy supplied to offices of twelve licensed
medical professionals located within Indiana.  Some patients that received products from those medical professionals may be live in states other than Indiana.  The
recall also includes approximately 400 prescriptions compounded for patients within Indiana and four other states: four prescriptions for patients in Illinois; and one
prescription each for patients in Ohio, Florida and Tennessee. See the firm press release for a list of products.

The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or
before Friday, April 19, 2013. To date, Nora has received no reports of injury or illness associated with the use of our sterile products. 

Consumers or health care providers with questions regarding this recall may contact Nora Apothecary & Alternative Therapies by phone at 800-729-0276
or 317-251-9547 from the hours of 9:30AM- 6:00PM Eastern Daylight Time Monday through Friday.
Patients who have received any product furnished by Nora Apothecary & Alternative Therapies and have concerns should contact their healthcare provider.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall - Communication Error When Attached to EtCO2 or SpO2 Modules

CareFusion Corporation has received reports of customers experiencing a communication error on the Alaris PC unit (model 8015) with software version 9.12
when attached to the Alaris EtCO2 module (model 8300) or the Alaris SpO2 module (models 8210 and 8220).The firm issued a recall notification letter informing
affected customers.  While toggling between the Alaris EtCO2 Main Screen, displaying the Capnography waveform, and the EtCO2 Limits screen, the Alaris PC unit may
experience a communication error. The communication error can also be experienced while toggling between the Alaris SpO2 Main Screen, displaying the Pleth waveform,
and the SpO2 Limits screen.  The Alaris PC unit will produce an audible alarm and the attached modules will display a Communications Error message with a flashing red
light. Refer to the Recall Notice for additional details.

When the Alaris PC unit experiences a communication error, the programmed infusion(s) will continue as programmed. However, no further key presses on the
Alaris PC unit have an effect on the system except for the System On key which allows the user to power down the device.  Powering down of the device results in
termination of all infusions. Termination of an infusion could result in serious injury or death.

The Alaris PC unit (model 8015) is part of the Alaris electronic infusion pump. An electronic infusion pump delivers controlled amounts of
medications or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
 
Either discontinue the use of the EtCO2 or SpO2 module(s) until the correction has been implemented by CareFusion, or weigh the risk/benefit to
patients before continuing to use the Alaris EtCO2 module or Alaris SpO2 module(s). If you experience a communication error on the Alaris PC unit, contact CareFusion
Customer Advocacy at 1-888-812-3266, 24 hours a day, 7 days a week.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Balanced Solutions All Sterile Compounded Products: Recall - Lack of Sterility Assurance

Balanced Solutions Compounding Pharmacy, LLC announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The
recall is being initiated due to concerns associated with quality control processes, which present a lack of sterility assurance. Patients are at increased risk for
infections in the event a sterile product is compromised. See the Press Release for a listing of affected products.

These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were
furnished nationwide. The sterile products include all injectables with the Balanced Solutions Compounding Pharmacy name.

Consumers or Health Care providers with questions regarding this recall may contact Balanced Solutions Compounding Pharmacy, LLC by phone at
407-936-2998 or 877-306-0008 from the hours of 9:30AM- 6:00PM Eastern Standard Time Monday-Friday.  Patients who have received
any product furnished by Balanced Solutions Compounding Pharmacy and have concerns should contact their healthcare provider.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Medical Bed Mattresses: FDA Safety Communication - Damaged or Worn Covers Pose Risk of Contamination and Infection

From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from
leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from
incorrect cleaning, disinfecting and laundering procedures. The zipper on the cover may also allow fluid to penetrate the mattress. Some reports indicate that if blood
and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for
infection if they come into contact with blood and body fluids from other patients.

Medical literature shows that damaged and wet (soiled) mattresses can be a source of contamination during infection outbreaks. The FDA is concerned that fluid ingress
from worn or damaged medical bed mattress covers may be widespread and largely under-recognized by health care providers, health care facility staff, and
caregivers. The FDA will continue to monitor this issue and keep the public informed if new information becomes available.

A medical bed mattress cover provides outer protection to a medical bed mattress by preventing blood and body fluids from entering the inside (inner
core) of the mattress. Medical bed mattress covers, whether water-resistant, water-proof, or water-repellent, may lose their effectiveness over time. The
duration of time that a medical bed mattress cover is expected to last (expected life) varies from manufacturer to manufacturer. In addition, the expected life of a
medical bed cover may differ from that of the mattress itself.
 
The Safety Communication lists several recommentations for inspection and maintenance including:   


  * Regularly check each medical bed mattress cover for any visible signs of damage or wear such as cuts, tears, cracks, pinholes, snags or stains. 
  * Routinely remove the medical bed mattress cover and check its inside surface. Once the mattress cover is removed, inspect the mattress for wet spots, staining,
or signs of damage or wear. Check all sides and the bottom of the mattress. 
  * Immediately replace any medical bed mattress cover with visible signs of damage or wear to reduce the risk of infection to patients. 
  * DO NOT stick needles into a medical bed mattress through the mattress cover. 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Stryker Orthopaedics – ShapeMatch Cutting Guide: Class 1 Recall

FDA notified healthcare professionals of a Class 1 recall for this product due to a software defect that results in wider cutting ranges. The parameters of the
manufactured cutting guides may not meet the surgeon’s pre-operative planning parameters entered via the web application. Additionally, Stryker Orthopaedics
determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) not matching the cutting guides produced. This may
result in serious adverse health consequences including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.

The FDA has received a total of 44 reports (41 malfunctions and 3 temporary medically reversible injuries) of incidents related to the ShapeMatch Cutting Guides.

The ShapeMatch Cutting Guides are single-use, disposable, cutting guides. They are intended to be used as surgical instrumentation to assist in the
positioning of total knee replacement (arthroplasty) components intraoperatively and in guiding the marking of bone before cutting. In November 2012, Stryker
Orthopaedics e-mailed field locations, registered surgeons and imaging centers of the problem and to immediately stop prescribing, planning or performing operative or
imaging procedures with the ShapeMatch Cutting Guides until further notice.

In January 2013, a Product Notification was issued to all branches, agencies, surgeons and risk managers at affected hospitals informing them of the problem and
risk mitigation factors. On April 10, 2013, Stryker issued an Urgent Medical Device Recall.

The ShapeMatch Cutting Guides have not been available on the market since November 2012. Stryker is recommending patients who had knee
replacement surgery in which ShapeMatch Cutting Guides were used and who are experiencing symptoms to contact  their surgeon. If symptom-free, the patient should
continue to follow-up with the surgeon as scheduled.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sterile Products Compounded, Repackaged, and Distributed by ApothéCure: Recall - Sterility Assurance Concerns

ApothéCure, Inc. is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. The recall is
being initiated due to the lack of sterility assurance and concerns associated with the quality control processes

The sterile products include all injectables with the clear message, “Independently tested for sterility,” noted on the vials as well as the Apothe’Cure
name. ApothéCure’s sterile products covered under this recall were distributed nationwide and supplied to the offices of licensed medical professionals. To date,
ApothéCure, Inc. has received no reports of injury or illness associated with the use of our sterile products. However, out of abundance of caution and in the
interest of our patients, ApothéCure, Inc. has decided to voluntarily proceed with this recall process.
 
Consumers or Health Care providers with questions regarding this recall may contact ApothéCure, Inc. by phone at 800-969-6601 or 972-960-6601 from
the hours of 9:30AM-6PM central time Monday-Friday. Patients who have received any product distributed by
Apothe’Cure and have concerns should contact their healthcare provider.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns

NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The
recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.

These products were supplied to the offices of licensed medical professionals. NuVision Pharmacy’s sterile products covered under this recall were
distributed nationwide. To date, NuVision Pharmacy has received no reports of injury or illness associated with the use of our sterile products. However, out of
abundance of caution and in the interest of our patients, NuVision Pharmacy has decided to voluntarily proceed with this recall process.

NuVision Pharmacy is notifying its customers by fax or email to return the products to the pharmacy. Consumers or Health Care providers with
questions regarding this recall may contact NuVision Pharmacy by phone at 800-914-7435 on Monday through Friday from the hours of 10 am to 6 pm CST.                                                                                                                                                                                          
Patients who have received any product distributed by NuVision Pharmacy and have concerns should contact their healthcare provider.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns

Green Valley Drugs notified healthcare professionals and their organizations about the recall of all lots of all sterile products compounded,
repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. A full list of the recalled
products (name, lot # and Beyond Use date) is linked from the press release or can be accessed at greenvalleymed.com. Green Valley Drugs sterile products covered under
this recall were distributed nationwide.

The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques. Green Valley has received no
reports of injury or illness associated with the use of the products.

Until further notice, healthcare providers should stop using all lots of sterile products and return them to the company. Consumers or healthcare
providers with questions regarding this recall may contact Green Valley Drugs by phone at 702-564-2079 Monday through Friday between the hours of 9 am to 5 pm PST.
Patients who have received any product distributed by Green Valley Drugs and have concerns should contact their healthcare provider.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall - Cables Are Not Transferring Alarms

Smiths Medical has become aware that, in rare instances, the BCI Remote Alarm Cables (BCI Cables) are not transferring alarms when used with some remote
nurse alarm systems. These products may cause serious adverse health consequences, including death.

The BCI Remote Alarm Cables are designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) System to transfer alarm signals from the
Capnocheck Capnography System to a remote alarm system. The BCI Remote Alarm Cables and the 9004 Capnocheck Capnography System are intended for use in all critical
environments including ventilator applications, patient transport, and anesthesia on patients ranging from pediatric to adult.

On Feb. 6, 2013, Smiths Medical sent its customers an "Urgent Medical Device Field Safety Notice-Recall" letter by UPS and customers were instructed to:

  * Inspect their inventory 
  * Remove all affected devices from use 
  * Complete and return the attached "Confirmation Form" by fax at 1-800-237-8033

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Animas Corporation 2020 Insulin Infusion Pump: Class I Recall - False Alarm or Warning Sound

Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may
trigger the pumps to sound a false alarm or warning related to one of the following:


  * “Loss of prime” 
  * “Occlusion” 
  * “No Cartridge detected” 

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety
instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in
danger of potential serious health risks, such as hypoglycemia.

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump
will no linger deliver insulin and will generate a “Call Service Alarm.”

The Animas 2020 Insulin Pumps are used to deliver insulin directly into your blood for the treatment of diabetes.

Customers with the device should contact Animas’ Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to
schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at
866-793-5253.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

BIVIGAM Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed

During a routine annual reserve inspection, visible particles were observed in lot number 120016 (Expiration Date: March 31, 2014) of BIVIGAM Immune Globulin
Intravenous (Human), 10% Liquid. Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible
particles.

BIVIGAM is indicated for the treatment of patients with primary humoral immunodeficiency (PI).

Consignees are asked to examine stocks immediately to determine if you have any of Lot 120016 on hand. If so, discontinue distributing the lot and
promptly return all vials to Biotest’s Boca Raton, Florida facility.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates

Hospira, Inc. notified healthcare professional of a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 1000 mL,
Flexible Container, NDC 0409-7983-09. This action is due to one confirmed customer report where brass particulate was identified in the primary container in the form
of several small grey/brown particles. The affected lot number is 25-037-JT (the lot number may be followed by a -01 or -90), with an expiration date of January 1, 2015.
Hospira is investigating to determine the root cause.

The brass particulate was identified as containing copper, zinc and lead. If administered, solution containing brass particulate may result in occlusion of small
blood vessels. In a worst-case scenario, copper toxicity may potentially result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal.

The product is used as a source of water and electrolytes and is packaged in a 1000 mL flexible container. The affected lot was distributed
nationwide between January 2013 and March 2013 to wholesalers/distributors, hospitals and pharmacies.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at
1-888-480-2853 between the hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is
available.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves: Class I Recall - Risk of Air Being Introduced Into Device

Model Numbers 8210, 8211, 8215, and 8216

FDA notified healthcare professionals of a Class I recall of the Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves, Model Numbers
8210, 8211, 8215, and 8216. The firm is recalling the product due to a risk that air may be introduced into the device which may lead to an air embolism. This product
may cause serious adverse health consequences, including death.

A list of the recalled lot numbers is available from Vascular Solutions and has been provided to each facility that purchased the affected products. The recalled
products were manufactured and distributed from February 2012 to February 2013.

The Guardian II and Guardian II NC hemostasis valves are intended to reduce blood loss during catheterization procedures.

On Feb. 28, 2013, Vascular Solutions sent an "Urgent Medical Device Recall" letter to its customers. The letter described the problem and the
product involved in the recall. The firm advised its customers to immediately remove the recalled product from their inventory and secure it.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed

Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since
January 1, 2013 to the user level, including all strengths, all dose forms, and all products within expiry date. Recent inspections conducted by the FDA and the
Massachusetts Board of Registration in Pharmacy found visible particulates (filaments) observed in vials of several different sterile compounded products. See
the Press Release for a listing of all products affected by this recall.

The potential public health risks are unknown as the particulate matter has not yet been identified. However, particulate matter has the potential to damage or obstruct
blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material.

The products are used for a wide range of therapeutic uses, including for treatment of erectile dysfunction, testosterone replacement therapy, vitamin
injections, and ophthalmic preparations. All products are packaged in glass vials.  All products were distributed to patients and/or physicians’ offices through Friday,
March 22, 2013.

Products were distributed directly to patients and/or physicians’ offices located in some or all of the following states: California, Connecticut, Florida, Georgia,
Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas,
Vermont, Virginia, and Wisconsin.

Users or recipients should discontinue use and return the recalled products to Pallimed. All users who received any of the recalled products have been
or will be notified by telephone, fax, electronic mail and/or regular mail of the recall. To return product, request assistance, or report complaints related to this
recall, users should contact Pallimed at www.pallimed.com and by telephone at (781) 937-3344, Monday through Friday, between 10:00 a.m. and 5:00 p.m.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Spacelabs Anesthesia Workstations and Service Kits: Class 1 Recall - Defect in CAS I/II Absorbers

Anesthesiology, Biomedical Engineering, Risk Managers

There is a defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits that may cause a condition leading to an increase in
the carbon dioxide concentration within the inhaled gas being delivered to the patient. This product may cause serious adverse health consequences, including
death. These products were manufactured and distributed from Oct. 31, 2012 to Jan. 15, 2013.

These products are used in the hospital environment and in locations not requiring mobility of the products. They provide respiratory support to deliver
oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to
deliver anesthetic vapor.

Immediately cease use of BleaseSirius and BleaseFocus Anesthesia Workstations shipped after Oct. 31, 2012. Immediately cease use of Service Kits Part
Number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a CAS I/II Absorber from a Service Kit. Advise staff of this situation. Customers may call
Spacelabs Medical at 1-800-522-7025 and select 2 for Technical support.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program 

Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance

Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility
assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.

This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious
eye infections associated with the use of the product. The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections,
which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties
Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.

Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to
the company. Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 Monday through Friday
between the hours of 10 am to 5 pm EST.  Patients who have received any product distributed by Clinical Specialties
Compounding and have concerns should contact their healthcare provider.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program 

Avastin Unit Dose Syringes by Clinical Specialties: Recall - Potential For Serious Eye Infection

Eye Care, Health Professional, Patient

Clinical Specialties is voluntarily recalling Avastin unit dose syringes.  The product has or potentially could result in an infection within the eye. Clinical
Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.

This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes (see
Press Release for a list of lot numbers). This product would be administered by a licensed physician in a surgery or physician’s office setting and syringes were
distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.

Doctors that have product which is being recalled should stop using the Avastin immediately. Consumers with questions regarding this recall may
contact Clinical Specialties by phone at 866-880-1915 Monday through Friday between the hours of 10 am to 5 pm
EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program 
Symbios GOPump Elastomeric Infusion PumpKit: Class 1 Recall - Flow Restrictor Bead May Become Displaced from its Fitting

Biomedical Engineering, Pain Management, Risk Managers

Symbios Medical Products, LLC sent its customers an "URGENT MEDICAL DEVICE RECALL" notification letter detailing the reason for recall and products listed. The
reason for the recall is that the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. This
product may cause serious adverse health consequences, including death. These kits were distributed between Sept. 10, 2012 and Feb. 11, 2013.  Refer to the Recall
Notice for a list of kit part numbers.

The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system using an inflatable elastomeric reservoir to
mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.

Customers are asked to: segregate recalled product, complete verification form, indicate returned products on verification form, obtain a returned goods authorization (RGA) number, and package the returned products. Refer
to the Recall Notice for details. 

 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program 

Med Prep Consulting Inc. Compounded Products: Recall - Potential Mold Contamination

Risk Manager, Pharmacy, Family Practice

Med Prep Consulting, Inc. notified the public that it is recalling all lots of all products compounded at its facility, due to lack of sterility assurance. The
level of recall is to the user: regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy
being notified by a Connecticut hospital that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML
FOR INJECTION intravenous solution, confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital.
At this time a total of five (5) contaminated bags were discovered. See the Med Prep Press Release for a list of affected products.

Administration of an intravenous product found to be contaminated with mold could result in a fatal infection in a broad array of patients.

The affected products are used for a wide range of therapeutic uses for hospitalized inpatients and outpatients, and, patients directly treated by a
health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to
home care patients for either self-administration or nursing administration.

All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. Products packaged in plastic infusion bags,
plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut,
and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physician’s office practice facilities and clinics. All of these
products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.

All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic mail and regular
mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390, Monday
through Friday, between 10:00 a.m. and 5:00 p.m. EST.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication - Reports of Serious
Tissue Damage and Patient Death

In the past 6 months, the FDA has become aware of additional death and injury reports related to these recalled devices. The patient death and
injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied and were associated with users of the device who had not been properly
trained on how to use the device.

Stryker and the FDA are particularly concerned about these cases, since a requirement for continuing to use these devices under the Certificate of Medical
Neccesity is to ensure that all users are adequately trained and have implemented the use of the Pre-use Checklist. 

Stryker issued updated recall notifications dated Feb. 20, 2013 for the Neptune 1 Silver and the Neptune 2 Ultra reminding customers of the steps they need to take to
continue using these devices. Health care facilities that must use these devices need to ensure the following steps are completed, as stated in their Certificate of
Medical Necessity:

  * Ensure ALL USERS of the Neptune 1 Silver and Neptune 2 Ultra are properly trained before the use of the device and aware of the risks associated with the device. 
  * Implement the Neptune Pre-use Checklist within your facility. This checklist must be completed BEFORE EVERY PROCEDURE for which a Neptune 1 Silver and/or
Neptune 2 Ultra device is used. 
  * Identify a training facilitator or device champion for each facility/hospital who will ensure the Neptune Pre-use Checklist is implemented consistently with
your facility’s standard protocol, and in a way that makes sense for your facility to document the checklist was completed. 
  * Prior to using the device, health care providers should follow the recommendations listed in the updated safety communication to mitigate the risks of using these devices. 
Older Alerts

 

 

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