FDA ISSUES NATIONWIDE/INTERNATIONAL ALERT ON POTENTIALLY DANGEROUS OB/GYN SURGICAL DEVICES

FDA is alerting consumers and health care professionals about medical devices labeled as sterile manufactured by A&A; of Alpharetta, Ga. and distributed nationally and internationally. The firm also does business as A&A; Medical/Rocket USA DBA LifeQuest. Some of the products manufactured by this company have been labeled and shipped internationally as sterile but in fact may not have undergone any sterilization process. This has the potential of causing death or serious injury such as infection, infertility, and miscarriage. This problem potentially affects product labeled and shipped as sterile since 1999.

This firm manufactures many types of obstetrics and gynecological surgical devices. These devices are used only in the clinical setting during surgical and gynecological procedures. These products include, but are not limited to curettes (flexible and rigid), uterine dilators, e.g. Laminaria, endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, harvesting pumps used in in-vitro fertilization, and aspiration sets.

FDA is urging the company to recall these products and will take the appropriate measures to assure these products are removed as soon as possible. Distributors and health care providers who have received these products should cease their distribution and use immediately.

Those seeking additional information may want to contact the company at 1-800-424-1234 or contact the FDA Center for Devices and Radiological Health in Rockville, Md. at 1-800-638-2041.

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