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FDA Issues Warning on Potentially Dangerous OB/GYN Devices

The Food and Drug Administration (FDA) issued a national and international alert yesterday warning consumers that obstetrics and gynecological surgical devices manufactured by A&A of Alpharetta, Georgia were incorrectly labeled sterile. The devices may not have undergone sterilization processes putting women at risk of death, infection, infertility, and miscarriage. According to the FDA, the devices may include endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, harvesting pumps used in in-vitro fertilization, and aspiration sets, among others. A&A makes products under the name A&A Medical/Rocket USA DBA LifeQuest.

Former employees of A&A alerted the FDA that unsterilized devices had been shipped in the same packages as sterilized devices. After investigating, the FDA found evidence in support of these claims. The FDA is now “urging the company to recall these products and will take the appropriate measures to assure these products are removed as soon as possible.”

For more information, the FDA advises consumers to contact A&A Medical at (8011) 424-1234 or the FDA Center for Devices and Radiological Health at (800) 638-2041.

Sources:

FDA News Release, 3/14/02; Kaiser Daily Reproductive Health Reports, 3/15/02

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