Recall Z-0985-2024— CooperSurgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2023-08-29. It names one FDA 510(k) clearance: K980123. Product: 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: Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-29
- Firm location
- Trumbull, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.