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 Passer
    • One (1) 5 mm Pilot Guide
    • One (1) 10/12 mm Pilot Guide
Lot codes and dates
  • UDI-DI
    • 60888937027053
    • lot# 326728
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:58 PM UTC

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