Drug recall
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number…
FDA recall event 96703 · Class II · Cook Incorporated
Key facts
| Event ID | 96703 |
|---|---|
| Recall numbers | Z-1786-2025, Z-1787-2025 |
| Recalling firm | Cook Incorporated |
| Product type | Devices |
| Products | Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,, Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957, |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. |
| Initiation date | Apr 17, 2025 |
| Report date | May 28, 2025 |
| 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: