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FDAAugust 29, 2023device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

What to do

FDA enforcement status: Ongoing

Brands named

coopersurgical

UPCs

60888937027053

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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