FDA answers questions on massive medical recall
Equipment may not have been sterilized
The Food and Drug Administration (FDA) has ordered A & A Medical Inc. in Alpharetta, GA, to recall all lots of medical devices labeled as "Sterile" or "Ethylene Oxide Processed" that were manufactured and distributed during the last three years by the firm. The firm also conducts business under the names LifeQuest Medical Inc. and Rocket USA (A & A).
The FDA has determined that there is a reasonable probability that use of these devices would cause serious, adverse health consequences or death because, contrary to their labeling, they may not have been subjected to a sterilization process. ICPs should check inventories and stop using and distributing these devices. The FDA has posted a Q&A document on the recall, which includes the following:
Q. What are the exact products, lot numbers and/or dates of distribution under recall?
A. This recall affects all lots of medical devices labeled as "Sterile" or "Ethylene Oxide Processed," manufactured and distributed over the past three years by a firm identified by any of three names: A & A Medical Inc., Rocket USA Inc., or LifeQuest Medical. It is also possible that some devices may have been distributed by an "own label distributor" and thus may have another firm’s label. Unfortunately, we do not have a reliable list of the firm’s "own label distributors." Devices include, but are not limited to: laminaria, rigid curved or straight curettes, aspiration kit w/sound, mucus samplers, OS dilator sets, miniembryon IUI (hard), insufflation tubing, Simms uterine curettes, Biere ovum forceps, Sopher ovum forceps, Hawkin-Ambler dilators, Kahn Uterine Trigger cannulas, and Pratt dilators. We are making every effort to contact ALL distributors and customers who have received devices from A & A over the past three years and provide them with appropriate recall information.
Q. Will I be reimbursed? Many hospitals, distributors and health care providers have experienced a problem trying to get this answer from the firm.
A. The FDA does not have an answer. The firm may no longer be in operation and has not as-sumed responsibility for the devices. The firm’s legal representative is Orrin Walker, 2291 Austell Road, Suite 107 Marietta, GA 30008, (770) 801-8600.
Q. Will the FDA reimburse me for recalled product?
A. No. It is the responsibility of A & A to provide refunds for the recalled product. The FDA is conducting this recall notification in the interest of public health.
Q. What should distributors, hospitals, and health care providers do with their recalled stock?
A. The FDA encourages that recalled devices be voluntarily destroyed. However, before destroying the recalled devices, complete a self-certification form and fax it to FDA’s Atlanta District Office (ATL-DO) at (404) 253-1201. (Form is available at www.fda.gov/cdrh/recalls/formaa.html.) The ATL-DO is asking for detailed information about the recalled devices and the place, date, and time when the devices will be destroyed, in the event FDA chooses to witness the destruction.
Q. How should the stock be destroyed?
A. We recommend that recalled devices be burned or pulverized. Please complete and mail the self-certification sheet before doing so.
Q. Can we re-sterilize the product?
A. It cannot be determined which of these devices have already been sterilized. The FDA is not aware of any data that would establish conditions for the safe, effective cleaning and subsequent re-sterilization of these devices. Therefore, it cannot recommend sterilization or re-sterilization.
Q. If I am a distributor, should I subrecall the product from accounts?
A. Yes. If you’ve distributed any of the devices, as labeled above or with your own label or another label, contact all your accounts and provide a copy of the FDA recall letter. Request that they immediately cease use and distribution of recalled devices and have them promptly return the devices to you. Or they may destroy the products themselves provided they fill out a self-certification form and fax it to FDA’s ATL-DO.
Q. If I have used this device on a patient, what should I do? If one of my patients has developed a problem possibly related to recall, what should I do?
A. The health care provider should make decisions about the most appropriate medical care for each patient. If you want to speak to an FDA medical officer (physician) regarding this issue, contact FDA’s Center for Devices and Radiological Health, Division of Small Manufacturers and International Consumer Assistance at (800) 638-2041. Provide your name and telephone number and an FDA medical officer will return your call. If you are aware of an adverse event involving these devices, or if you become aware of one, please contact the FDA at the numbers shown. Health care providers employed by health care facilities that are subject to FDA’s user facility-reporting requirements should follow the reporting procedures established by their facility. All other providers may submit their reports to MedWatch, the FDA’s voluntary reporting program. Reports can be submitted by phone: (800) FDA-1088; fax: (800) FDA-0178; MedWatch web site: www.fda.gov/medwatch; or by mail: 5600 Fishers Lane, Rockville, MD 20852-9787.