FDAFDA · Food and drugs·Recall number Z-0045-2025
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.
Published October 16, 2024 · Recall initiated: September 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Incorporated
- Distributor
- International distribution to the country of Australia.
- Lot
- UDI-DI: 00827002272422; Lot Number: 15506769
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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