Cook recalls Check=Flo Performer Introducer devices with incorrectly sized introducer sheaths. Affected units may cause complications during medical procedures. Contact Cook for details.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Cook is recalling Check=Flo Performer Introducer medical devices that may have incorrectly sized introducer sheaths. This could lead to complications during medical procedures if used improperly.
The introducer sheath may be the wrong size for the device, which could cause complications during medical procedures. This risk is specific to the medical context where precise sizing is critical.
Medical professionals using the Check=Flo Performer Introducer devices are most at risk. Patients receiving procedures with these devices may be affected.
Check for the Reference Part Number REF RCFW-10.0-0-38-30-RB or Order Number G08686 on the device. Devices with UDI/DI 00827002086869 and Lot Number 16376248 are affected.
Verify the Reference Part Number (REF RCFW-10.0-0-38-30-RB) or Order Number (G08686) on the device.
The affected model is Check=Flo Performer Introducer, 10.0Fr with Reference Part Number REF RCFW-10.0-0-38-30-RB.
Check for the Reference Part Number REF RCFW-10.0-0-38-30-RB or Order Number G08686 on the device. Affected units also have UDI/DI 00827002086869 and Lot Number 16376248.
The recall record does not specify a remedy, so contact Cook Incorporated directly for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1786-2025 — Cook Cook Hello, I own a Cook that is covered by recall Z-1786-2025 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
