FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0045-2025
·
Reported October 16, 2024
Enforcement
- Recall Number
- Z-0045-2025
- Event ID
- 95405
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 16, 2024
- Initiation Date
- September 16, 2024
- Classification Date
- October 9, 2024
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120, United States
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.
Reason
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.
Code Info
UDI-DI: 00827002272422; Lot Number: 15506769
Distribution
International distribution to the country of Australia.
Quantity
50 units