Jim Vititoe | September 1, 2010
FOR IMMEDIATE RELEASE
August 31, 2010
Release #10-329 Firm’s Recall Hotline: (800) 291-4289
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
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. It [...]
Category: Consumer Alert, FDA, Medical Warning, U.S. Consumer Product Safety Commission |
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Jim Vititoe | April 29, 2010
Safety Announcement
02-22-2010] The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia* (rosiglitazone). The clinical study, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes or RECORD study was designed to evaluate [...]
Category: FDA, Health Alert, Medical Warning |
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Jim Vititoe | March 24, 2010
FOR IMMEDIATE RELEASE - March 12, 2010 - Limerick, PA - Teleflex Incorporated provided an update today on the previously announced Arrow International, Inc. voluntary recall of ALL lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010.
Testing revealed [...]
Category: Health Alert, Medical Recall, Medical Warning |
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Tags: compromised packaging
Jim Vititoe | March 24, 2010
FDA NEWS RELEASE
For Immediate Release: March 22, 2010
Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as Agency Learns More
FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United [...]
Category: FDA, Health Alert, Medical Recall, Medical Warning |
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Jim Vititoe | March 24, 2010
FDA NEWS RELEASE
For Immediate Release: March 19, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567; elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Highest approved dose of cholesterol-lowering medication could cause harm to muscles
The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor [...]
Category: FDA, Medical Warning |
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Tags: muscle injury
Jim Vititoe | March 17, 2010
FDA NEWS RELEASE
For Immediate Release: March 11, 2010
Counterfeit polypropylene mesh products marketed as C. R. Bard/Davol
The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where [...]
Category: Medical Recall, Medical Warning |
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Tags: Counterfeit polypropylene mesh
Jim Vititoe | March 17, 2010
FDA NEWS RELEASE
For Immediate Release:
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Maalox product maker agrees to name change to avoid confusion
The U.S. Food and Drug Administration today warned consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the [...]
Category: Medical Warning |
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Tags: maalox
Jim Vititoe | March 17, 2010
FDA NEWS RELEASE
For Immediate Release:
Rare, but serious, liver disorder reported in some patients
The U.S. Food and Drug Administration announced on January 29 that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine).
Videx is an antiretroviral medicine first approved by the FDA in [...]
Category: FDA, Medical Warning |
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Jim Vititoe | February 3, 2010
FDA notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System, Model number GEF09800, because of reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. It is possible to [...]
Category: FDA, Medical Recall, Medical Warning |
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Jim Vititoe | February 3, 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 [...]
Category: FDA, Medical Recall, Medical Warning |
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