Recall Z-3025-2011 ยท HDC Tenaculum, Uterine
GYN Disposables Inc
GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.
| Date | Aug 15, 2011 (initiated Jul 29, 2011) |
| Status | Terminated |
| Reason | Lack of sterility assurance. |
| Root cause | Process design |
| Action | GYN Disposables Inc. sent out an "Urgent: Medical Device Recall" letter dated July 29, 2011 to all affected customers The letter includes: product affected, description of problem and asks customers quarantine all affected product. They can contact GYN Disposables to have the product picked up and to receive credit. A Response Form is also included. For questions on this recall call (888) 372-2203, extension 101. |
| Quantity | 3987 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073182 | GYN DISPOSABLES TENACULUM 356T Gyn-Disposables, Inc., Nov 28, 2007 |