Z-0985-2024 Class II Ongoing
FDA device recall Z-0985-2024 was initiated by CooperSurgical, Inc. on August 29, 2023 and is designated Class II. Reason for recall: Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. The recall status is ongoing. Affected quantity: 127 boxes, 3 kits per box (381 kits total).
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- August 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127 boxes, 3 kits per box (381 kits total)
Product 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 for Recall
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Distribution Pattern
US Nationwide distribution in the state of MO.
Code Information
UDI-DI: 60888937027053, lot# 326728.