Cook recalls Flexor Check-Flo Introducer models with incorrect radiopaque marker placement that may cause longer procedures during medical imaging. Affected lots include GPN G09908, lot 13861362.
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 certain Flexor Check-Flo Introducers because the radiopaque marker band might be placed incorrectly. This could lead to longer procedures during medical imaging if the device is used without proper identification under fluoroscopy.
The radiopaque marker band may be located just below the proximal fitting instead of the distal tip. This incorrect placement could cause the device to be misidentified during fluoroscopy, leading to longer procedures and potential delays in treatment.
Healthcare professionals using the Flexor Check-Flo Introducer for medical procedures are most at risk if they use the recalled models without proper identification under fluoroscopy.
Check for the product name 'Flexor Check-Flo Introducer' with model RPN KCFW-6.0-35-45-RB and lot number 13861362. The affected items have the serial number GPN G09908.
Verify the product model number and lot number on the device to determine if it's affected.
The radiopaque marker band may be incorrectly placed, which could lead to misidentification during fluoroscopy and longer procedures.
The recall does not specify a remedy, so contact Cook Inc. for further instructions.
Check for the model RPN KCFW-6.0-35-45-RB and lot number 13861362 with serial number GPN G09908.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0185-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-0185-2022 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.
