FDA-Device2024-10-16Class II
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.
Hazard
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.
Sold states
International distribution to the country of Australia.
Affected count
50 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0045-2025More Cook Incorporated recalls
- FDA-Device2026-04-15Cook Medical arterial pressure monitoring trays recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Strange Bile Duct Stone Exploration Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Wayne Pneumothorax Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Blue Rhino G2 tracheostomy introducer tray recalled for incorrect expiration dates
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief