Z-0985-2024Class II

Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as...

Name: Z-0985-2024 Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as...
Creator: CooperSurgical, Inc.
Published: 2023-08-29
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2023-08-29 / Open, Classified / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of 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... on 2023-08-29. FDA classified it as Class II and gives the reason as "Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0985-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-29
Posted: 2024-02-05
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Root cause tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 127 boxes, 3 kits per box (381 kits total)
Distribution: US Nationwide distribution in the state of MO.
Product codes and lots: UDI-DI: 60888937027053, lot# 326728.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0985-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0985-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-05

Product code GCJ

K980123Class IICarter-Thomason Needle-Point Suture Passer Instrument SetLouisville Laboratories, Inc. / cleared 1998-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)