Drug recall
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer…
FDA recall event 95405 · Class II · Cook Incorporated
Key facts
| Event ID | 95405 |
|---|---|
| Recall numbers | Z-0045-2025 |
| Recalling firm | Cook Incorporated |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Sep 16, 2024 |
| Report date | Oct 16, 2024 |
| City | Bloomington |
| State | IN |
| Country | United States |
| FEI number | 1820334 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: