CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL,
Recalled 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.
Hazard / Issue
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Issued by
FDA
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