FDA Device recall Z-1786-2025
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686
- FDA Device
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686 by Cook, citing cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1786-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-17 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | US |
Product
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Reason
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Identifiers
| code_info | UDI/DI 00827002086869, Lot Number 16376248 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1786-2025%22
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