Friday, February 8, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 7 Feb 2008 14:06:09 -0600 (CST)
Subject: FDA Clears for Market First Decellularized Heart Valve

FDA Clears for Market First Decellularized Heart Valve
Thu, 7 Feb 2008 12:15:00 -0600

The U.S. Food and Drug Administration today cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed.


Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 7 Feb 2008 15:07:53 -0600 (CST)
Subject: New Era Canning Company Announces New Nationwide Recall of Vegetable Products in #10 cans (6 to 7 pound cans) (Feb. 7)

New Era Canning Company Announces New Nationwide Recall of Vegetable Products in #10 cans (6 to 7 pound cans) (Feb. 7)
Thu, 7 Feb 2008 13:50:00 -0600

New Era Canning Company of New Era, Michigan is recalling all cans of vegetable products in #10 cans (large cans containing between 6 and 7 pounds) on the list below because they may have been processed under conditions which could have led to contamination by Clostridium botulinum bacterium spores, which can cause life-threatening illness or death.


Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 7 Feb 2008 17:05:48 -0600 (CST)
Subject: New Era Canning Company Expands Nationwide Recall

New Era Canning Company Expands Nationwide Recall
Thu, 7 Feb 2008 15:56:00 -0600

The U.S. Food and Drug Administration (FDA) is alerting consumers, food service operators, and food retailers that New Era Canning Company, New Era, Mich., is broadening its nationwide recall of canned vegetable products for a third time because of the potential for its foods to be contaminated with Clostridium botulinum (C. botulinum).


Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 7 Feb 2008 15:29:16 -0600 (CST)
Subject: Failure to Reactivate ICDs after Surgery Can Lead to Adverse Events

An FDA article in the February edition of Nursing2008 describes the case of a middle-aged man who died after uneventful elective surgery because no one turned his implantable cardioverter defibrillator (ICD) back on after the procedure. The patient’s ICD had been inactivated before the surgery because exposure during surgery to any electromagnetic interference (EMI), and particularly to electrocautery devices, can cause ICD malfunction. To read more about preventing these incidents click here. 


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