Recall Z-1782-2014 ยท LKF Cannula, Manipulator/Injector, Uterine
CooperSurgical, Inc.
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
| Date | Jun 11, 2014 (initiated May 13, 2014) |
| Status | Terminated |
| Reason | Sterility of the device may be compromised due to unsealed pouch |
| Root cause | Process control |
| Action | Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200. |
| Quantity | 1180 units |
| Distribution | Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER Ackrad Laboratories, Apr 9, 1997 |