FDAFDA · Food and drugs·Recall number Z-0985-2024
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.
Published February 14, 2024 · Recall initiated: August 29, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CooperSurgical, Inc.
- Distributor
- US Nationwide distribution in the state of MO.
- Lot
- UDI-DI: 60888937027053, lot# 326728.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.