Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential 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 because the sheath might separate during use, leading to serious risks such as vessel injury or bleeding. This could happen in medical procedures and requires immediate attention.
The sheath may separate at the connection point during use, which could lead to serious issues like bleeding, vessel damage, or blockage of blood flow to vital organs. This separation might occur during medical procedures and requires immediate action.
Medical professionals using the recalled Flexor Check-Flo Introducers for vascular procedures are most at risk, as separation could cause life-threatening complications during treatment.
Check the product's lot number on the packaging or label. The recalled items have specific lot numbers: 13297248, 13318063, 13320595, 13334764, 13388304, 13435140, 13291880X, NS13246556, NS13265340, NS13288123.
Immediately stop using the recalled Flexor Check-Flo Introducers if you have them, as separation could cause life-threatening complications.
The recalled product is the Flexor Check-Flo Introducer with model RPN KCFW-8.0-35-70-RB-HFANL0-HC and order number G56223.
Check the lot number on the product label; the recalled items have specific lot numbers: 13297248, 13318063, 13320595, 13334764, 13388304, 13435140, 13291880X, NS13246556, NS13265340, NS13288123.
If separation occurs, it could lead to life-threatening events such as vessel injury, bleeding, or blockage of blood flow to vital organs.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0608-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0608-2021 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.
