Check=Flo Performer Introducer recall
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Why was Check=Flo Performer Introducer recalled?
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00827002089570, Lot Number 16376242
- Product
- Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
- Recalling firm
- Cook Incorporated
- Quantity
- 89 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
- Recall date
- May 28, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)