FDA Device recall Z-0985-2024
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems by Coopersurgical, citing incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0985-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-29 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
Reason
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Identifiers
| code_info | UDI-DI: 60888937027053, lot# 326728. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0985-2024%22
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