Neuron 6F 070 Delivery Catheter – Penumbra
October 8, 2009
Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death. There are four injury reports to date, which may be potentially associated with this defect.
Philips Recalls Select Heartstart Fr2+ Automated External Defibrillators
October 4, 2009
Philips is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall.
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
October 2, 2009
The U.S. Food and Drug Administration (FDA) is alerting healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later. This change—largely in response to the 2007-2008 heparin contamination problem—will include a new USP reference standard and test method that is used to determine the potency of the drug. The new test method, unlike the previous method, is able to detect impurities that may be present in heparin. The monograph change will also harmonize the USP unit dose with the WHO International Standard (IS) unit dose.
Penumbra Recalls the Original Version of 6F Neuron 070 Delivery Catheter
October 1, 2009
Penumbra is initiating a voluntary Field Removal of the original version of Neuron 6F 070 Delivery Catheter. For these catheters, Penumbra has received feedback from some users that the catheter could kink or ovalize in certain anatomical situations. This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death.
Nationwide Recall of Neocate Infant Specialized Formula Lot P91877
September 29, 2009
Nutricia North America, Inc. (“Nutricia”) has contacted customers to undertake the voluntary recall and replacement of one (1) lot of the specialized infant formula product, Neocate®. This recall involves a limited quantity of individual cans (approximately 3700) from Lot # P91877, and does not affect any other Neocate® products or lot numbers.
Portex Uncuffed Pediatric-Sized Tracheal Tubes
September 22, 2009
Smiths Medical announced that it is initiating a nationwide voluntary recall of Portex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before September 2009.
FDA Warning: Do Not Use Stolen Albuterol Sulfate and Ipratropium Bromide Inhalation Solutions
September 18, 2009
The U.S. Food and Drug Administration advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.
LIFEPAK CR Plus Automated External Defibrillators
September 17, 2009
FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy.
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
September 17, 2009
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.
Arbonne International, LLC Recalls One Lot of Seasource Detox Spa Foaming Sea Salt Scrub
September 12, 2009
Arbonne International, LLC (“Arbonne”) has voluntarily recalled one lot of its Seasource Detox Spa® Foaming Sea Salt Scrub. The recalled products were manufactured by a third party and distributed nationwide through Arbonne Independent Consultants. The product comes in a 6.8 fluid oz white tube and is identified with a lot number on the crimping at the top of the tube. The Seasource Detox Spa Foaming Sea Salt Scrub products affected by this voluntary recall are ONLY from the following lot number (with shipping dates ranging from March 28, 2008 to July 15, 2009):
Smiths Medical Issues Urgent Device Recall Of Portex Pediatric-Sized Tracheal Tubes
September 12, 2009
Smiths Medical announced that it is initiating a nationwide voluntary recall of Portex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before
September 2009.
CONMED Corporation Recalls Certain Powered Surgical Instrument Products
September 12, 2009
CONTACT: CONMED Corporation
Robert Shallish
Chief Financial Officer
315-624-3206
- PRODUCTS INCLUDED IN THE RECALL:
* PRO5 and PRO6 Series Handpieces Manufactured and Distributed Prior to May 31, 2008
* MC5057 Universal Cable Manufactured and Distributed Prior to December 1, 2006
Penumbra Neuron 5F Select Catheter
September 12, 2009
Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.
Qualitest Pharmaceuticals Recalls Accusure Insulin Syringes
August 22, 2009
Qualitest Pharmaceuticals, Inc., has issued a voluntary nationwide recall of Accusure® Insulin Syringes (1/2 cc – 31 G – Short Needle) with lot number 6JCB1 (Expiration 10/2011) – NDC 0603-7001-21. This lot was distributed between January 2007 and June 2007 to wholesalers and retail pharmacies nationwide (including Puerto Rico). Also today, Qualitest has issued a voluntary nationwide recall of Accusure® Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21 This lot was distributed between May 2007 and June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots have been found to have needles which can detach from the syringe.
Nutracoastal Trading LLC Expands Its Voluntary Nationwide Recall Of Steam Dietary Supplement
August 19, 2009
Hospira Issues Urgent Device Recall For AC Power Cords
August 15, 2009
Hospira, Inc. (NYSE: HSP), is initiating a nationwide recall of certain Hospira devices that have defective AC power cords manufactured by Electri-Cord Manufacturing Corporation. This recall is being issued in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira’s investigation of these reports determined that the power cord’s prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death. The products affected by this recall include:
Barr Laboratories Issues Nationwide Recall of Certain Dextroamphetamine Amphetamine 20mg Tablets
August 15, 2009
Barr Laboratories, Inc. has recalled Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product identified is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.
Carefusion Issues Update Regarding Previously Disclosed Recall of the Alaris
July 31, 2009
CareFusion Corporation, which is expected to become a public company following its planned spinoff from Cardinal Health, today issued the following update regarding its previously disclosed recall of the Alaris System:
Abbott Issues Voluntary Recall of POWERSAIL Coronary Dilatation Catheters
July 31, 2009
Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.
Nutracoastal Trading Recalls STEAM Dietary supplement lot 80214
July 30, 2009
Nutracoastal Trading LLC announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement product sold under the following name: STEAM.
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