Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
FDA device recall Z-1630-2015 · posted 2015-05-19 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- NLM
- Quantity affected
- 430 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2015-03-20
- Date posted
- 2015-05-19
- Date terminated
- 2015-07-29
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPROCESSED CLOSURE SYSTEM (K133414) | Sterilmed, Inc. | 2014-01-22 |