—#91531

Product

TAUT ADAPt Balloon Open Access Port And Syringe 10/12mm x 100mm, REF 41244, Rx Only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Intended use: The ADAPt Balloon Open Access Port is indicated for the use in thoracic, abdominal and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices. This a single use device, provided sterile.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K082156
Affected lot / code info: Catalog Number: 41244, Serial/Lot number: 01E0900215

Why it was recalled

Balloon does not hold air or water once inflated.

Root cause (FDA determination)

Other

Action the firm took

The firm, Teleflex Medical, sent an "Urgent Medical Device Recall" letter dated May 10, 2010 to customers The letter described the product, problem and action to be taken by the customers. They were instructed to return all of the affected product to Teleflex. Each distributor was instructed to forward the letter to their customers to retrieve relevant product from those locations. A second mailing to non-responding customers will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, email, or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. Teleflex Medical will communicate to FDA on the status of recall activities. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: Worldwide distribution: USA including states of AR, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NY, OR, PA, WI, WV and country of France.

Timeline

Recall initiated: 2010-05-12
Posted by FDA: 2010-06-23
Terminated: 2010-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.