# FDA recall Z-0985-2024

> **CooperSurgical, Inc.** · Class II · device recall initiated 2023-08-29.

## 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 for recall

Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

## Distribution

US Nationwide distribution in the state of MO.

## Key facts

- **Recall number:** Z-0985-2024
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-29
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trumbull, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0985-2024

## Citation

> AI Analytics. FDA recall Z-0985-2024. Retrieved 2026-09-22 from https://api.ai-analytics.org/recall/Z-0985-2024. Source: US FDA. Licensed CC0.

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