Z-1787-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2025
- Initiation Date
- April 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 units
Product Description
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Reason for Recall
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
Code Information
UDI/DI 00827002089570, Lot Number 16376242