medical Class II Updated 2024-10-16

Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RC

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: International distribution to the country of Australia.
Lot/Code Info: UDI-DI: 00827002272422; Lot Number: 15506769
View official government recall

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