Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation during use, which could cause life-threatening complications like hemorrhage or vessel injury.
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, risking life-threatening events such as bleeding or vessel damage. Affected units have specific lot numbers and should be checked for safety.
The introducer sheath can separate at the connection point during use. If this happens, it may cause bleeding, block blood flow to vital organs, or require emergency intervention.
Medical professionals using the Flexor Check-Flo Introducers for vascular procedures are most at risk, particularly those with the listed lot numbers.
Check the lot numbers listed in the recall: 13135824, 13140931, 13141304, and other specific numbers provided in the notice. These units were sold with the model RPN KCFW-6.0-35-55-RB-HFANL1-HC.
Immediately stop using the recalled Flexor Check-Flo Introducers with the listed lot numbers as they pose a risk of life-threatening separation.
The recalled product is the Flexor Check-Flo Introducer with model RPN KCFW-6.0-35-55-RB-HFANL1-HC.
Affected lot numbers include 13135824, 13140931, 13141304, and many others listed in the recall notice.
The sheath can separate during use, potentially causing life-threatening events like bleeding or vessel injury.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0599-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0599-2021 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.
