Medical Device Recall: 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
Cook Incorporated · September 16, 2024
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.
Product Description
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.
Distribution
International distribution to the country of Australia.
Quantity Affected
50 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0045-2025
Status: ongoing
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