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 Flexor Check-Flo Introducers with certain lot numbers because the sheath may separate during use, potentially causing life-threatening events such as vessel injury or hemorrhage. This recall affects medical devices used in vascular procedures.
The introducer sheath may separate at the proximal bond site during use. If separation occurs, it can lead to life-threatening events including vessel injury, hemorrhage, or embolization that blocks blood flow to vital organs.
Healthcare professionals using the recalled Flexor Check-Flo Introducers for vascular procedures are at risk. Patients undergoing these procedures with the recalled devices could face serious complications.
Check the lot numbers listed: 13143101, 13150445, 13159707, 13159715, 13166166, 13168195, 13186332, 13186337, 13214441, 13217127, 13221797, 13223835, 13229666, 13237660, 13246546, 13249446, 13262327, 13265329, 13291866, 13294513, 13307179, 13318024, 13332149, 13332159, 13337780, 13337796, 13346086, 13352434, 13352441, 13354252, 13366190, 13366197, 13382711, 13396125, 13398833, 13398835, 13413758, 13420106. The product is used in vascular procedures by medical professionals.
Immediately stop using the recalled Flexor Check-Flo Introducers with the listed lot numbers as they pose a risk of life-threatening separation.
The introducer sheath may separate at the proximal bond site during use, which could cause vessel injury, hemorrhage, or embolization blocking blood flow to vital organs.
Lot numbers: 13143101, 13150445, 13159707, 13159715, 13166166, 13168195, 13186332, 13186337, 13214441, 13217127, 13221797, 13223835, 13229666, 13237660, 13246546, 13249446, 13262327, 13265329, 13291866, 13294513, 13307179, 13318024, 13332149, 13332159, 13337780, 13337796, 13346086, 13352434, 13352441, 13354252, 13366190, 13366197, 13382711, 13396125, 13398833, 13398835, 13413758, 13420106.
Immediately stop using it and contact Cook for instructions on how to return or dispose of the device safely.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0601-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0601-2021 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.
