Cook recalls Flexor Check-Flo Introducers and Sets with specific part numbers due to potential manufacturing defects that may cause improper length, trimming, or inspection.
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Cook is recalling Flexor Check-Flo Introducers and Sets with certain part numbers because they may have been manufactured incorrectly, potentially leading to improper length or trimming. This could affect medical procedures using these devices.
The recalled products may have been cut to the wrong length, not trimmed correctly, or not inspected properly during manufacturing. This could lead to improper function during medical procedures, but the risk of serious injury is not explicitly stated.
Medical professionals who use these devices during procedures are most at risk. Patients using these devices are not directly affected as they are not the ones using the devices.
Check the part numbers listed in the recall notice. These include specific reference part numbers like KCFW-9.0-18/38-45-RB-ANL0-HC and others listed in the product details.
Review the part numbers and lot numbers provided in the recall notice to determine if your device is affected.
The affected part numbers include KCFW-9.0-18/38-45-RB-ANL0-HC, KCFW-9.0-18/38-45-RB-ANL1-HC, KCFW-10.0-35-45-RB-HFANL0-HC, and others listed in the recall notice.
No, the recall does not require immediate discontinuation. However, you should check if your device is affected and take appropriate action if it is.
The recall does not specify a remedy, so you should contact Cook directly for further instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0993-2026 — Cook Cook Hello, I own a Cook that is covered by recall Z-0993-2026 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.
