Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Syst...
FDA Recall #Z-0985-2024 — Class II — August 29, 2023
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.
Recalling Firm
CooperSurgical, Inc. — Trumbull, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
127 boxes, 3 kits per box (381 kits total)
Distribution
US Nationwide distribution in the state of MO.
Code Information
UDI-DI: 60888937027053, lot# 326728.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated