Cook Flexor Check-Flo Introducer Ansel Modification: Mislabeling Risk

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Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Cook is recalling a specific model of vascular introducer device because it may be mislabeled, causing 6FR and 7FR devices to be mixed. This could lead to incorrect device use in medical procedures.

Why it’s dangerous

The device may be mislabeled, meaning products labeled as 6FR could contain a 7FR device and vice versa. This mismatch could cause incorrect device sizing during medical procedures, potentially leading to complications.

Who’s affected

Healthcare professionals using the Flexor Check-Flo Introducer Ansel Modification model KCFW-7.0-18/38-45-RB-ANL0-HC. Patients receiving procedures with this device may be at risk if mislabeled devices are used.

How to tell if you have this one

Check for the model number KCFW-7.0-18/38-45-RB-ANL0-HC and order number G44155 on the device packaging. Products labeled with 6FR may contain a 7FR device and vice versa.

Brand
Cook
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for the model number KCFW-7.0-18/38-45-RB-ANL0-HC and order number G44155 on the device packaging.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled device?

The model number is KCFW-7.0-18/38-45-RB-ANL0-HC.

Why is this device being recalled?

The device may be mislabeled, causing 6FR and 7FR devices to be mixed, which could lead to incorrect device sizing during medical procedures.

What should I do if I have this device?

Check the device label for the model number KCFW-7.0-18/38-45-RB-ANL0-HC and order number G44155. If mislabeled, contact Cook for guidance.

Take action

Contact Cook

We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0388-2022 — Cook Cook

Hello,

I own a Cook that is covered by recall Z-0388-2022 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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Where this comes from

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.

Official source: FDA Recall #Z-0388-2022 (November 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0388-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Cook Inc. recalls Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155

Lower-risk recall