Cook recalls Flexor Check-Flo Introducer Ansel Modification Model KCFW-6.0-18/38-45-RB-ANL0-HC due to mislabeling that may mix 6FR and 7FR devices, potentially causing incorrect use.
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Cook is recalling a specific medical device model because it may be mislabeled, leading to 6FR and 7FR devices being mixed up. This could cause incorrect use in medical procedures, though the recall does not specify immediate harm.
The device may be mislabeled, causing 6FR and 7FR devices to be mixed up. This could lead to incorrect use in medical procedures, though the recall does not specify immediate harm.
Healthcare professionals using this device for medical procedures are most at risk. Patients receiving treatments with this device may also be affected if mislabeled units are used.
Check for the model number KCFW-6.0-18/38-45-RB-ANL0-HC and order number G44154 on the device packaging. Products with a label stating 6FR may contain a 7FR device and vice versa.
Look for the model number KCFW-6.0-18/38-45-RB-ANL0-HC and order number G44154 on the device packaging.
The device may be mislabeled, causing 6FR and 7FR devices to be mixed up, which could lead to incorrect use in medical procedures.
Check the device label for the model number KCFW-6.0-18/38-45-RB-ANL0-HC and order number G44154. If it matches, you may need to verify with your healthcare provider.
The recall does not specify a risk of serious injury; it focuses on potential mislabeling that could lead to incorrect use.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0387-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-0387-2022 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.
