Gynecology

FDA issues international warning on possibly dangerous instruments

Published in Medical Letter on the CDC and FDA, April 14th, 2002

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...

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Source: Medical Letter on the CDC and FDA (2002-04-14)

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