Cook recalls Flexor Check-Flo Introducer with incorrect radiopaque marker band placement, potentially causing longer procedures during medical imaging. Affected lots may need replacement.
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
Cook is recalling Flexor Check-Flo Introducer sets that may have the radiopaque marker band incorrectly placed. This could lead to longer procedures during medical imaging if the device is used improperly.
The radiopaque marker band may be located just below the proximal fitting instead of the distal tip. This error can only be detected when the device is placed in a patient and viewed under fluoroscopy, potentially increasing procedural time during medical procedures.
Healthcare professionals using the Flexor Check-Flo Introducer set for medical procedures are most at risk if the device is used without proper identification of the radiopaque marker band.
Check for the product model RPN KCFW-5.0-38-90-RB-RAABE with lot number 13846597. The device is sold by Cook Inc. for medical use.
Identify the lot number on the device packaging or label to determine if it is affected.
The recall is happening because affected lots may have the radiopaque marker band incorrectly placed, which could lead to longer procedures during medical imaging if not identified properly.
Check for the product model RPN KCFW-5.0-38-90-RB-RAABE with lot number 13846597 on the device packaging or label.
The recall record does not specify a remedy, so contact Cook Inc. 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-0186-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-0186-2022 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.
