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U.S. Department of Health and Human Services

Safety

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A & A Medical/Rocket USA/Lifequest Ob/Gyn and Surgical Products

Audience: Hospital Administrators, Risk Managers, Department of Obstetrics and Gynecology

The FDA Center for Devices and Radiological Health notified healthcare professionals of a recall of all medical devices manufactured by A & A Medical, Inc. of Alpharetta, GA, labeled as sterile and shipped since 1999 nationwide because they may not have undergone sterilization. As a result, these devices could cause serious and possibly life-threatening infections. This firm manufactures many types of Ob/Gyn and surgical devices. The recall includes, but is not limited to curettes (flexible and rigid), uterine dilators, fetal blood samplers, and laparoscopy accessories. See the link below for a current list of known products affected by this recall.

[March 19, 2002 - Safety Alert - FDA]