FDA recall Z-0985-2024

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

Status

Ongoing

Initiation date

2023-08-29

Report date

2024-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Trumbull, CT, United States

Primary source

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