AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.
Create a link to this page
Copy and paste this link tag into your Web page or blog:
FDA issues international warning on possibly dangerous instruments.(Brief Article)
2002 APR 11 - (NewsRx.com & NewsRx.net) -- The U.S. government sent doctors an urgent warning March 14, 2002 that a Georgia-based manufacturer may not have sterilized numerous devices used in births, infertility treatments and other gynecology procedures - posing a risk of life-threatening injuries.
The Food and Drug Administration said the potentially dangerous devices, made by A&A Medical of Alpharetta, Georgia, were sold nationwide and in Canada, Egypt, Lebanon and Italy.
The FDA said it was urging A&A to voluntarily recall the devices. A message left March 14, 2002, with the company was not immediately returned.
"We're going to take the action necessary to make sure the products are taken off the market," FDA enforcement chief Larry Spears said.
Former company employees told the FDA that sterile and nonsterile devices had been shipped together in the same batches, and agency inspectors who visited the company facilities found evidence supporting ...
- FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related...
- Press release article from: M2 Presswire October 3, 2008 700+ words
...US Food and Drug Administration: FDA Issues Interim Safety and Risk Assessment...Contamination (Sept. 23, 2008) FDA Updates Health Information Advisory...Contamination (Sept. 20, 2008) FDA Issues Health Information Advisory on Infant...
- FDA issues rules on tampon absorbency; manufacturers are now required to follow...
- Magazine article from: Nonwovens Industry Mayberry, Peter December 1, 1989 700+ words
FDA Issues Rules on Tampon Absorbency In late October, the Food and Drug Administration (FDA) released final rules that will require tampon...also be required to follow a standardized, FDA-approved test to measure fluid absorbency...
- FDA Issues Warning Letter to Melanocorp, Inc. For Illegal Sale of Melanotan II...
- Press release article from: M2 Presswire September 5, 2007 700+ words
M2 PRESSWIRE-5 September 2007-US FDA: FDA Issues Warning Letter to Melanocorp, Inc. For Illegal Sale...05092007 The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner...
- FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an ImportAlert for...
- Press release article from: M2 Presswire September 18, 2008 700+ words
...US Food and Drug Administration: FDA Issues Warning Letters to Ranbaxy Laboratories...The Food and Drug Administration (FDA) today issued two Warning Letters...extent and nature of the violations, FDA today issued an Import Alert, under...
- FDA issues rare company-wide warning letter to Boston Sci.
- Newspaper article from: Medical Device Daily January 30, 2006 700+ words
FDA issues rare company-wide warning letter to Boston...Indianapolis) for about $27.2 billion, the FDA warned it of company-wide quality failures...conference call on the warning letter, one FDA official noted that this was only the third...
- FDA issues draft guidance on license applications for certain...
- Press release article from: M2 Presswire January 18, 2007 700+ words
M2 PRESSWIRE-18 January 2007-US FDA: FDA issues draft guidance on license applications for certain placental...LTD RDATE:16012007 The Food and Drug Administration (FDA) today issued a draft guidance recommending a streamlined...
- FDA Issues Public Health Advisory on Chantix Agency requests that manufacturer...
- Press release article from: M2 Presswire February 4, 2008 700+ words
...US Food and Drug Administration: FDA Issues Public Health Advisory on Chantix Agency...S. Food and Drug Administration (FDA) today issued a Public Health Advisory...stop smoking. On Nov. 20, 2007, FDA issued an Early Communication to the...
- FDA Issues Safety Alert on Avandia.
- Press release article from: M2 Presswire May 22, 2007 700+ words
M2 PRESSWIRE-22 May 2007-US FDA: FDA Issues Safety Alert on Avandia(C)1994-2007 M2 COMMUNICATIONS...21052007 The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia...
Source: HighBeam Research, FDA issues international warning on possibly dangerous...