Reported Feb 14, 2024 · Ongoing
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled:…
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- Box as labeledRegard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems
- Kit as labeledRegard, Carter-Thomason CloseSure System, REF 733776
- Contents
One (1) Carter-Thomason Suture PasserOne (1) 5 mm Pilot GuideOne (1) 10/12 mm Pilot Guide
- Lot codes and dates
- UDI-DI
60888937027053lot# 326728
- UDI-DI
- Amount recalled
- 127 boxes, 3 kits per box (381 kits total)
Where it was sold
- Nationwide
- MO
Why it was recalled
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
This product could cause temporary or reversible health problems — stop using it.
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