Device 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.
Z-0985-2024
Product summary
- Event
- Event 93822
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 127 boxes, 3 kits per box (381 kits total)
- Official record key
device-enforcement:Z-0985-2024
Official wording
Reason: Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Code information: UDI-DI: 60888937027053, lot# 326728.
Distribution pattern: US Nationwide distribution in the state of MO.
Derived failure modes
-
Unknown
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.