Medical Device Recall: 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-Th
CooperSurgical, Inc. · August 29, 2023
Reason for Recall
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
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.
Distribution
US Nationwide distribution in the state of MO.
States Affected
NATIONWIDE
Quantity Affected
127 boxes, 3 kits per box (381 kits total)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0985-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.