Recall Z-1630-2015 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
CooperSurgical, Inc.
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
| Date | May 19, 2015 (initiated Mar 20, 2015) |
| Status | Terminated |
| Reason | The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes. |
| Root cause | Component design/selection |
| Action | Consignees were notified of the recall by letter sent via FedEx dated March 20, 2015. The letter instructs consignees to do the following: discontinue use of the affected product, complete the attached acknowledgement and receipt form to return the product and schedule a replacement. |
| Quantity | 430 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133414 | REPROCESSED CLOSURE SYSTEM Sterilmed, Inc., Jan 22, 2014 |