FDA-Device2024-02-14Class II
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.
CooperSurgical, Inc.
Hazard
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Sold states
US Nationwide distribution in the state of MO.
Affected count
127 boxes, 3 kits per box (381 kits total)
Manufactured in
95 Corporate Dr, Trumbull, CT, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0985-2024Don't want to check this manually?
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