Recall archive / FDA device enforcement
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers... — FDA record Z-0045-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 16, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- 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.
- Classification
- Class II
- Recalling firm
- Cook Incorporated
- Quantity
- 50 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0045-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00827002272422; Lot Number: 15506769 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Australia.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 16, 2024
- Recall initiation date
- Sep 16, 2024
- Center classification date
- Oct 9, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.