The Medicines Company Expands a Nationwide Recall for Certain Lots of Cleviprex That May Contain Particulate Matter
March 18, 2010
Teleflex Incorporated Announces Worldwide Voluntary Recall of Arrow Select IV Tubing Sets, Accessories, and Certain Embolectomy Catheters
March 16, 2010
LifeScan Recalls 8 Lots of OneTouch, SureStep Test Strips Due To Inaccurate
February 27, 2010
LifeScan, Inc. is recalling eight lots of OneTouch ® SureStep ® Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
Acacia Recalls IV Extension Sets with BD Q-Syte Luer Access Device
February 10, 2010
Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company). Use of the affected BD Q-Syte™ Luer Access Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action included notification to customers worldwide by letter.
Cardiac Science Notifies AED Customers of Medical Device Recall
February 10, 2010
Cardiac Science Corporation [NASDAQ: CSCX] is initiating a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The FDA has been informed of this situation.
BD Announces Worldwide Voluntary Recall ofBD Q-Sytea Luer Access Devices and BD Nexiva Closed IV Catheter Systems
February 10, 2010
Becton, Dickinson and Company is recalling certain lots of BD Q-Syte ™ Luer Access Devices and BD Nexiva ™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action included notification to customers worldwide by letter. Neither the costs anticipated with the recall, nor the impact on BD’s business, are expected to be material.
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.
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.
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.
-
Sponsors
