Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Reported: May 28, 2025 Initiated: April 17, 2025 #Z-1786-2025
Product Description
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Reason for Recall
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 99 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,. Recalled by Cook Incorporated. Units affected: 99 units.
Why was this product recalled? ▼
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2025. Severity: Moderate. Recall number: Z-1786-2025.
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