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.
Cook Incorporated
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-0045-2025Don't want to check this manually?
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