Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 00827002089570, Lot Number 16376242
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cook Incorporated
- Reason for Recall:
- Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Product Codes/Lot Numbers:
UDI/DI 00827002089570, Lot Number 16376242
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1787-2025
Related Recalls
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Incorporated
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.