Register for FDA announces the destruction of unsafe medical devices
RecallsAugust 12, 2002
The U.S. Food and Drug Administration (FDA) announced in July that products manufactured by A & A Medical, Inc./Rocket USA/LifeQuest Medical, Inc. of Alpharetta, Georgia, were destroyed on July 11, 2002, as a result of regulatory action by FDA.
On April 9, all in-house sterile product inventory, consisting of approximately 40,000 units, was seized by FDA. The products are estimated to be valued at approximately $200,000.00. All of the firm's products labeled as sterile or ethylene oxide processed and shipped since 1999 nationwide were recalled by FDA in the spring of 2002.
The FDA Center for Devices and Radiological Health notified health care professionals of a recall of all medical devices manufactured by A & A Medical, labeled as sterile or ethylene oxide processed and shipped since 1999 nationwide, because they may not have undergone sterilization. As a result, these devices could have caused serious and possibly life-threatening infections. No complaints of injury were reported.
This small firm with approximately 10 employees manufactured several types of OB/GYN and surgical devices. The owners of the company left the country after the FDA investigation revealed serious sterilization issues. The destruction included curettes (flexible and rigid), uterine dilators, fetal blood samplers, and laparoscopy accessories. This article was prepared by Medical Devices & Surgical Technology Week editors from staff and other reports.
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