Recall Z-0147-2015 ยท DRC Trocar
CooperSurgical, Inc. D.B.A. Lone Star Medical Products
Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
| Date | Oct 29, 2014 (initiated Sep 13, 2013) |
| Status | Terminated |
| Reason | CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper. |
| Root cause | Error in labeling |
| Action | CooperSurgical sent an Urgent Field Safety Notice ( Correction ) dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm provided correct package inserts (IFU) to affected consignees. The recalling firm intends to conduct effectiveness checks by reviewing return receipts from the initial recall communication. We apologize for any inconvenience this communication may cause. If you have any questions or concerns, please contact CooperSurgical at (203) 601-9818. |
| Quantity | 90 units |
| Distribution | Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911462 | SURGICAL TROCAR Applied Medical, Apr 22, 1991 |