[pending] Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order
Pending LLM rewrite. Source: FDA_DEVICE Z-1786-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
The recalled product
- Product
- Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00827002086869
- Lot Number 16376248
Distribution
Distributed nationwide across the United States.
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