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CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: R
Recalled February 14, 2024 · FDA recall Z-0985-2024 · CooperSurgical
Hazard
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. · FDA Class II
Units
127 boxes, 3 kits per box (381 kits total)
Sold at
US Nationwide distribution in the state of MO.
Description
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
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.
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →