FDA Device recall Z-1630-2015
Carter-Thomason II Port Closure System
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of Carter-Thomason II Port Closure System by Coopersurgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1630-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-20 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
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.
Identifiers
| code_info | Lot 174422 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1630-2015%22
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