FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: 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 number
- Z-0985-2024
- Recalling firm
- CooperSurgical, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2023-08-29
- Posted
- 2024-02-05
- Terminated
- not on file
- Reason
- Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
- Root cause
- Labeling Change Control
- Action
- 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 Recall@coopersurgical.com.
- Quantity
- 127 boxes, 3 kits per box (381 kits total)
- Distribution
- US Nationwide distribution in the state of MO.
- Lot, serial or model codes
- UDI-DI: 60888937027053, lot# 326728.
- 510(k) numbers
- ["K980123"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28