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.
Recall
- Recall Number
- Z-0985-2024
- Event Number
- 93822
- Firm
- CooperSurgical, Inc.
- FEI Number
- 1216677
- Product Code
- GCJ
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- August 29, 2023
- Posted
- February 5, 2024
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350
Description
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.
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
An Urgent Medical Device Field Safety Notice dated August 29, 2023 was sent to the one distributor receiving shipments of the affected product lot. Customers are advised to complete the acknowledgement form, Affected product is to be returned to CooperSugical for credit. Contact CooperSurgical at +1-203-601-5200 extension 3300 during normal operating hours of 09:00 - 17:00 M-F EST, email [email protected].
US Nationwide distribution in the state of MO.
127 boxes, 3 kits per box (381 kits total)