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The U.S. Food and Drug Administration has urged a manufacturing firm to recall potentially dangerous gynecological surgical devices that may be mislabeled as sterile, and the agency cautions risk managers that they should be on the lookout for the items in their own facilities.
The devices were manufactured by A & A of Alpharetta, GA, and distributed internationally, the FDA said in a statement. The firm also does business under the name A & A Medical, Rocket USA, and LifeQuest, the regulatory agency said.
David W. Feigal Jr., MD, MPH, director of the FDA’s Center for Devices and Radiological Health, issued a letter addressed directly to health care risk managers. He cautions that the items manufactured by A & A Medical "may not have undergone sterilization even though they may be labeled as sterile or ethylene oxide-processed. As a result, these devices could cause serious and possibly life-threatening infections."
The recall includes all products labeled as sterile and shipped since 1999 nationwide and internationally. Feigal explains that the products may be sold by firms other than A & A Medical and its other company names. The FDA is working to identify all distributors of the products, and a list of distributors and the products they receive from A & A Medical is being placed on FDA’s web site at www.fda.gov/cdrh/recalls/recall31402.html.
The recall includes all products manufactured under the name A & A Medical, Rocket USA, or LifeQuest that are labeled as sterile or as ethylene oxide processed. The firm manufactures numerous OB/GYN and surgical devices. The recall includes, but is not limited to, curettes (flexible and rigid), uterine dilators, fetal blood samplers, and laparoscopy accessories. A list of known products is attached.
The FDA advises against using any A & A Medical, Rocket USA, or LifeQuest products. This is a partial list of items manufactured by A & A: curette (flexible and rigid, all sizes), collection set tubing, aspiration sets, laminaria, IUD removal instruments, mucus samplers, biopsy pipettes/ endometrial sampling sets, uterine sounds, Pratt dilator set, ovum forceps, tenaculum forceps, needle extenders and guide, fetal bladder drain, fetal blood sampler, harvesting pump and accessories, loop/ball electrodes, laparoscopy accessories.
The agency also suggests you periodically consult the FDA web site for a listing of distributors of A & A Medical products. If you have any products from these distributors, contact the distributor for further instructions. Not all of the distributors’ products may be affected by this recall.
For more information, the FDA suggests calling the company at (800) 424-1234 or (770) 343-8400. You also can contact the FDA’s Center for Devices and Radiological Health in Rockville, MD, at (800) 638-2041.