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.
Reported: February 14, 2024 Initiated: August 29, 2023 #Z-0985-2024
Product 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.
Reason for Recall
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 127 boxes, 3 kits per box (381 kits total)
- Distribution
- US Nationwide distribution in the state of MO.
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CooperSurgical, Inc.. Units affected: 127 boxes, 3 kits per box (381 kits total).
Why was this product recalled? ▼
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0985-2024.
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