FDA recall Z-0045-2025

Cook Incorporated · Class II · device

Product

Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.

Reason for recall

Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.

Distribution

International distribution to the country of Australia.

Key facts

Status
Ongoing
Initiation date
2024-09-16
Report date
2024-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0045-2025