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 they may separate during use, leading to serious risks such as vessel injury or bleeding. This recall affects medical devices used in vascular procedures.
The introducer sheath can separate at the connection point during medical procedures. If this separation happens, it may cause bleeding, vessel damage, or block blood flow to vital organs, leading to serious health issues.
Medical professionals using the recalled Flexor Check-Flo Introducers for vascular procedures are at risk of life-threatening complications if the sheath separates during use.
Check the lot numbers listed: 13229667, 13231805, 13254613, 13291858, 13291869, 13310725, 13318020, 13337787, 13337798, 13346070, 13354237, 13366209, 13369431, 13375208, 13391162, 13407499, 13435157, NS13401856. The product is sold under order number G56228.
Discontinue use of the recalled Flexor Check-Flo Introducers with the listed lot numbers as they pose a life-threatening risk.
The recalled device is the Flexor Check-Flo Introducer with order number G56228 and specific lot numbers listed in the recall notice.
If separation occurs, it could lead to life-threatening complications such as vessel injury, bleeding, or blockage of blood flow to vital organs.
Check the lot numbers on your device: 13229667, 13231805, 13254613, 13291858, 13291869, 13310725, 13318020, 13337787, 13337798, 13346070, 13354237, 13366209, 13369431, 13375208, 13391162, 13407499, 13435157, NS13401856.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0609-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0609-2021 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.
