The U.S. Food and Drug Administration has announced that products manufactured by A & A Medical Inc./Rocket USA/LifeQuest Medical Inc. of Alpharetta, Ga., were destroyed July 11 as a result of regulatory action by the FDA. On April 9, all in-house sterile product inventory, consisting of approximately 40,000 units, was seized by the 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 the FDA in spring 2002.
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 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 have been 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.
The FDA is responsible for enforcing the Federal Food, Drug and Cosmetic Act. The agency’s mission is to promote and protect the public health by helping safe and effective products reach the market place, and seeing that products which can be misbranded, adulterated or harmful do not reach the market place.