March 15, 2002
Director, Central Supply
|Director, Department of Obstetrics and Gynecology|
Director, Department of Surgery
Ambulatory Surgical Centers
I am writing to alert you to a recall of all medical devices manufactured by A & A Medical, Inc. of Alpharetta, GA because they 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.
Other Companies Affected by the Recall
Please note that these products may be sold by firms other than those listed above. FDA is working to identify all distributors of these products. A list of distributors and the products they receive from A & A Medical is being placed on FDA's web site at http://www.fda.gov/cdrh/recalls/recall31402.html. We will continue to update this list until all distributors have been identified and listed. In addition, these distributors are being asked to contact all customers who received the affected products.
Products Included in the Recall
This 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. This firm manufactures many types of 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.
- Do not use any A & A Medical, Inc., Rocket USA, or Lifequest products.
- Periodically consult the FDA web site for a listing of distributors of A & A Medical, Inc. 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.
Individuals seeking additional information should call the company at 1-800-424-1234 or 770-343-8400 or contact FDA's Center for Devices and Radiological Health, Rockville, Maryland at 1-800-638-2041. Additional information regarding this recall can also be found on the FDA's MedWatch web site at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00799.html.
Should you have questions regarding this letter, please contact, Jan Davis, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, by fax at 240-276-3356, or by e-mail at email@example.com. Additionally, a voice mail message may be left at 240-276-3357 and your call will be returned as soon as possible.
All of the FDA medical device postmarket safety notifications can be found on the World Wide Web at Alerts and Notices (Medical Devices). Postmarket safety notifications can also be obtained through e-mail on the day they are released by subscribing to our list server. You may subscribe at http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10.
Reporting Adverse Events to FDA
The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices, including the recalled devices. We request that you follow the procedures established by your facility for such mandatory reporting.
We also encourage you to report medical device malfunctions. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA's voluntary reporting program. You may submit reports to MedWatch one of four ways: online at http://www.accessdata.fda.gov/scripts/medwatch/ by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
David W. Feigal, Jr., MD, MPH
Center for Devices and Radiological Health
Food and Drug Administration
List of Known Ob/Gyn and Surgical Devices Recalled by A & A Medical, Inc.
(This is a partial list; as known at the time of this alert.)
- Curette (flexible and rigid, all sizes)
- Collection set tubing
- Aspiration sets
- 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