Stryker Operating Room System II Surgical Navigation System – Recall
December 11, 2009
Recall Class: Class I
Date Recall Initiated: October 26, 2009
Product: Operating Room System II Surgical Navigation Systems
| Product Name | Stryker Catalog Number | Serial#/Lot# Range |
| Navigation System II-Cart | 7700-100-000 | Serial #s 100715-100735 |
| PC SPC-1 Assembly | 7700-101-201 | Lot # K7P00F6000 |
Bayer Recalls One Lot of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gel Combo Packs
December 9, 2009
In consultation with the U.S. Food and Drug Administration (FDA), Bayer’s Consumer Care division has begun a voluntary recall of a single product lot of the combination package of Alka-Seltzer Plus® Day & Night Cold Formula Liquid Gels. Bayer initiated the recall after identifying that the labeling on the foil blister card of certain packages within the lot (less than 4 percent) were printed with the label reversed. All individual liquid filled capsules are imprinted correctly.
Cardiovascular Systems ViperSheath Sheath Introducer – Recall
December 5, 2009
Recall Class: Class I
Date Recall Initiated: October 21, 2009
Product:
ViperSheath Sheath Introducer is manufactured by Thomas Medical Products, Inc. and is distributed by Cardiovascular Systems, Inc. (CSI).
Lot Ranges Catalog Numbers
S28117 through S29174 VPR-ISH 5 X 85, VPR-ISH 6 X 85,
VPR-ISH 7 X 85, VPR-ISH 5 X 45,
VPR-ISH 6 X 45, VPR-ISH 7 X 45
Stryker Corporation’s Instruments Division Issues Worldwide Class 1 Recall of 23 Operating Room System II Surgical Navigation Systems
November 26, 2009
Stryker Corporation’s Instruments division initiated a worldwide, Class 1 recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all. The potential harms associated with this failure are: delay in surgery, reschedule of the procedure resulting in an additional surgery, risk of infection, increased morbidity, potential neurological deficits, or injury due to the surgeon operating in an area where they did not intend to operate. Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death. There have been no reports of injury.
P&G Recalls Specific Lots of Vicks Sinex Nasal Spray
November 20, 2009
The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom.
RockHard Laboratories Recalls Specific Lots of RockHard Weekend marketed as Dietary Supplement
November 18, 2009
RockHard Laboratories announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement sold under the name RockHard Weekend (RHW) specific to the following Lot Numbers:
Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12)
3ct Bottle: R417 0509 (exp: 09/12)
8ct Bottle: T237-0509 (exp: 06/12)
Cardiovascular Systems Recalls ViperSheath Sheath Introducer
November 18, 2009
Cardiovascular Systems, Inc. has announced a voluntary recall of all lots of the ViperSheathTMSheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009.
Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction
November 15, 2009
Cardiac Science Corporation is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device’s periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.
IDS Sports Conducts a Voluntary Nationwide Recall of Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR
November 14, 2009
IDS Sports announced today that it is conducting a voluntary nationwide recall of five of the company’s dietary supplement products sold under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR.
GMP Herbal Products Recalls Weight Loss Supplement Found to Contain Undeclared Drug Ingredients
November 14, 2009
GMP Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as drug; therefore the safety and effectiveness of this product is unknown. All lots of the following Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder.
Hospira Recalls Certain Lots of Liposyna and Propofol Products: May Contain Particulate Matter
November 10, 2009
Hospira, Inc. (NYSE: HSP), a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposynâ?¢ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall.
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
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