CooperSurgical, Inc. Recall 93822
Description: 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.
CooperSurgical, Inc. Recall 93822 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0985-2024 |
| Event ID | 93822 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of MO. |
| Quantity | 127 boxes, 3 kits per box (381 kits total) |
| Recall Reason | Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. |
| Device Classification | 20240214 |
| Device Code Info | UDI-DI: 60888937027053, lot# 326728. |
| Center Classification Date | 20240205 |
| Recall Initiation Date | 20230829 |
| Recalling Firm | CooperSurgical, Inc. |
| Initial Notification | Letter |
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