Edwards Lifesciences Aquarius Hemodialysis System
January 29, 2010
FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
Hettich Centrifuges with 2050 and 2076 Plastic Rotors
January 29, 2010
FDA notified healthcare professionals of a Class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors, used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. The recall was initiated because the plastic centrifuge rotor may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed. This may result in serious personal injury and damage to the surrounding area.
Recalled Infusion Set Needles Manufactured by Nipro for Exelint
January 29, 2010
Recall Classification: Class I
Date Recall Initiated: December 23, 2009
Product Names:
* Exel Huber Needles
* EXELint Huber Needles
* Exel Huber Infusion Sets
* EXELint Huber Infusion Sets
* Exel “Securetouch+” Huber Safety Sets
* EXELint Huber Safety Sets
ALL LOT NUMBERS BEGINNING WITH 07, 08, OR 09 ARE AFFECTED BY THIS RECALL.
FDA Recalls Exel/Exelint Huber Needles
January 28, 2010
FDA Announces Class I Recall of Certain Infusion Set Needles
Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions
The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.
Hettich Centrifuges Recalls Plastic Hematocrit Rotors: Injury Risk
January 23, 2010
Hettich Centrifuges, Beverly, MA, is initiating a North America and Canada recall of 2050 and 2076 plastic hematocrit rotors that are used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. These plastic rotors have the potential to break apart resulting in pieces of the rotor to be forcefully ejected through the plastic centrifuge housing. This may result in serious personal injury and damage to the surrounding area.
Nipro Medical Recalls GlucoPro Insulin Syringes
January 23, 2010
Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.
MuscleMaster.com Recalls Certain BodyBuilding Products
January 16, 2010
MuscleMaster.com is recalling all lots and expiration dates of the seventeen below listed dietary supplements sold between June 1, 2009 and November 17, 2009.
McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products
January 16, 2010
Please see our post from yesterday regarding this OTC medication recall by McNeil Consumer Healthcare.
Defibrillator Recall Advice
January 12, 2010
There are many manufacturers of Automated External Defibrillators (AEDs). Although the units must pass the same rigid FDA tests in order to be marketed to the public, when it comes to recalls, all units are not alike.
ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall
January 7, 2010
Product Name: Trailblazer Support Catheter
Model Numbers
SC-014-135, SC-018-090,
SC-035-065, SC-035-135,
SC-014-150, SC-018-150,
SC-035-090, SC-035-150.
Lot Numbers
7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, 7832205.
Nationwide Recall Of All Lots Of Tylenol Arthritis Pain 100 Count With Ez-Open Cap
December 29, 2009
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall to include all available product lots of TYLENOL ® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The recall is being expanded, as a precaution, to include all TYLENOL ® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP.
Encompass Group Recalls Thermoflect Product Line
December 29, 2009
Jea R. Gackowski, Encompass Group Corporate Compliance Officer announced today the company is voluntarily recalling the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment.
Teva Animal Health, Inc. Expands Recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials
December 22, 2009
Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.
Vicks Dayquil Cold & Flu Liquicaps Recalled by Procter & Gamble
December 19, 2009
WASHINGTON, D.C. – THE U.S. CONSUMER PRODUCT SAFETY COMMISSION, IN COOPERATION WITH THE FIRM NAMED BELOW, TODAY ANNOUNCED A VOLUNTARY RECALL OF THE FOLLOWING CONSUMER PRODUCT. CONSUMERS SHOULD STOP USING RECALLED PRODUCTS IMMEDIATELY UNLESS OTHERWISE INSTRUCTED.
NAME OF PRODUCT: VICKS DAYQUIL COLD & FLU 24-COUNT BONUS PACK LIQUICAPS
The Medicines Company Recalls Certain Lots of Cleviprex: Particulate Matter
December 17, 2009
The Medicines Company (NASDAQ: MDCO) announced today that it is voluntarily recalling eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials during a routine annual inspection. The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. No other lots are affected by this recall.
Atlas Operations Recalls Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements
December 15, 2009
Pompano Beach, FL – Atlas Operations, Inc. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements for sexual enhancement sold under Lot Numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 & 807.
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.
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