Pointe Scientific Liquid Glucose Hexokinase Reagent – Recall
November 7, 2009
Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.
Centurion Medical Products Premie Pack and Meconium Pack Recall
November 5, 2009
| Recall Class: | Class I | ||
| Date Recall Initiated: |
September 22, 2009 | ||
| Product: | Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115
|
American Regent Expands Voluntary Recall to Include All Lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials
November 5, 2009
Shirley, NY – American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 15 mg/mL:
NDC# 0517-0601-25 15 mg/mL 1mL Single Dose Vial
BODYBUILDING.COM Conductings International Recall of 65 Dietary Supplements That May Contain Steroids
November 4, 2009
This post has been moved to: Bodybuilding.com Supplements May Contain Steroids.
Pointe Scientific Expands Recall of Liquid Glucose Hexokinase Reagent (G7517)
November 1, 2009
Pointe Scientific, Inc. is recalling all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.
Distributors and testing laboratories who have received the Pointe Scientific, Inc Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.
Cordis Recalls Crpsspver Sheath Introducer
October 31, 2009
Cordis Corporation announced today a nationwide voluntary recall of all lots of the CROSSOVER™ Sheath Introducer due to complaints about stretching or fracture of the sheath during use.
Pointe Scientific Recalls Liquid Glucose Hexokinase Reagent (G7517)
October 31, 2009
Pointe Scientific, Inc, Canton, MI is initiating a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.
Qualitest Pharmaceuticals Issues a Voluntary Nationwide Recall of All Accusure® Insulin Syringes
October 28, 2009
Huntsville AL-Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, NDC 0603-7000-21, 31G 1/2cc, NDC 0603-7001-21; and 31G 1cc, NDC 0603-7002-21. All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.
San Link Inc. Issues an Alert on Uneviscerated Vacuum Pack Dried Krasnoperka (Fish).
October 28, 2009
American Regent Recalls All Lots of Ketorolac Tromethamine Injection
October 22, 2009
American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:
NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial
NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)
Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators
October 8, 2009
Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.unomedical.com/?pageid=H3160.This recall is being conducted because of a potential malfunction of certain units of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death. This recall does not impact any MPRs manufactured after March 2008.
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.
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