Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to increased risk of sheath separation during use, which could cause life-threatening complications like vessel injury or hemorrhage.
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Cook is recalling certain Flexor Check-Flo Introducers that may separate during use, potentially causing life-threatening events such as vessel injury or hemorrhage. Affected users should stop using the device immediately to avoid serious health risks.
The introducer sheath can separate at the proximal bond site during use, which may lead to life-threatening events including vessel injury, hemorrhage, or blockage of blood flow to vital organs.
Medical professionals using the Flexor Check-Flo Introducer for vascular procedures are most at risk, particularly those with the specific lot numbers listed in the recall.
Check the lot number on the device, which is listed in the recall (e.g., 13192055, 13200423, etc.). The product is sold under the brand Cook and model RPN KCFW-7.0-35-55-RB-HFANL1-HC.
Immediately stop using the Flexor Check-Flo Introducer if it has the listed lot numbers, as separation could cause life-threatening complications.
The recalled device is the Flexor Check-Flo Introducer with model RPN KCFW-7.0-35-55-RB-HFANL1-HC and specific lot numbers listed in the recall.
If separation occurs, it could result in life-threatening events such as vessel injury, hemorrhage, or blockage of blood flow to vital organs.
Check the lot number on the device against the list provided in the recall (e.g., 13192055, 13200423, etc.).
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0603-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0603-2021 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.
