CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Box as labeled: Regard, Carter-Thomason CloseSure System XL recalled
CooperSurgical is recalling Box as labeled: Regard, Carter-Thomason CloseSure System XL, distributed nationwide in the US. The recall was initiated on 29 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0985-2024
- FDA event ID
- 93822
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Aug 2023
- FDA classified
- 5 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 29 Aug 2023 | Recall initiated by company | |
| 5 Feb 2024 | Classified by FDA | +160 days |
| 14 Feb 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the state of MO.
Questions about this recall
Why was it recalled?
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Which lots are affected?
UDI-DI: 60888937027053, lot# 326728.
Where was it sold?
US Nationwide distribution in the state of MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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