Check-Flo Performer Introducer Set — Class II medical device recall Z-0045-2025
Ongoing recall by Cook Incorporated, reported 2024-10-16. Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the w
| Recall number | Z-0045-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2024-09-16 |
| Classified | 2024-10-09 |
| Reported by FDA | 2024-10-16 |
| Countries outside the US | AU |
| Quantity | 50 units |
| UPC / GTIN / UDI-DI | 00827002272422 |
| Lot numbers | 15506769 |
| Model numbers | RCF-5.0-35-45-J |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0045-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.