Carter-Thomason II Port Closure System — Class II medical device recall Z-1630-2015
Terminated recall by CooperSurgical, Inc., reported 2015-05-27, distributed nationwide. The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been
| Recall number | Z-1630-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2015-03-20 |
| Classified | 2015-05-19 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2015-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 430 units |
| Lot numbers | 174422 |
| Model numbers | CTI-1015P |
Product
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1630-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.