Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which may 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 they can separate at the connection point during use. This separation could lead to serious complications such as vessel injury or bleeding, requiring immediate medical attention.
The sheath can separate at the proximal bond site during use, potentially causing the introducer to become dislodged. This may lead to vessel injury, bleeding, or blockage of blood flow to vital organs, requiring emergency intervention.
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 lot numbers listed: 13089576, 13105053, 13130281, and other specific numbers provided in the recall notice. The product is a Flexor Check-Flo Introducer with order number G56220.
Discontinue use of the recalled Flexor Check-Flo Introducers with the listed lot numbers as they pose a risk of separation during procedures.
The recalled product is the Flexor Check-Flo Introducer with order number G56220 and specific lot numbers listed in the recall notice.
If separation occurs, it could result in life-threatening complications such as vessel injury, bleeding, or blockage of blood flow to vital organs, requiring immediate medical attention.
Check the lot numbers on your product: 13089576, 13105053, 13130281, and other specific numbers provided in the recall notice.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0596-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0596-2021 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.
