FDA recalls OB/GYN Equipment
WASHINGTON, D.C. - Officials at the Food and Drug Administration (FDA) are alerting healthcare workers internationally of a medical device recall.
Equipment manufactured by A&A, also known as A&A Medical/Rocket USA and Lifequest, of Alpharetta, Ga., is being recalled because it was incorrectly labeled as "sterile."
The products did not undergo a sterilization process. Their use could cause death or infection, infertility or miscarriage. The devices recalled include: flexible and rigid curettes, uterine dilators, endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, aspiration sets, biopsy pipettes and harvesting pumps used during in-vitro fertilization. They are being recalled from the US, Canada, Egypt, Italy and Lebanon.
For more information about the recall, healthcare workers ca contact the company at 1-800-424-1234 or the FDA at 1-800-638-2014.
