FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0985-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0985-2024
- Event ID
- 93822
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CooperSurgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- August 29, 2023
- Classification Date
- February 5, 2024
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350, United States
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.
Reason
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Code Info
UDI-DI: 60888937027053, lot# 326728.
Distribution
US Nationwide distribution in the state of MO.
Quantity
127 boxes, 3 kits per box (381 kits total)