CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL,
See all recalls from CooperSurgical, Inc. →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
Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 60888937027053, lot# 326728.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
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