Recall Z-1890-2010 ยท GCJ Laparoscope, General & Plastic Surgery
Teleflex Medical
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,
| Date | Jun 23, 2010 (initiated May 12, 2010) |
| Status | Terminated |
| Reason | Balloon does not hold air or water once inflated. |
| Root cause | Other |
| Action | 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 s |
| Quantity | 366 eaches |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082156 | ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 Teleflex Medical, Sep 10, 2008 |