Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation causing life-threatening events like embolization or vessel injury during medical procedures.
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, potentially causing life-threatening complications such as vessel injury or embolization. This recall affects medical devices used in vascular procedures.
The introducer sheath may separate at the connection point during use, which can lead to life-threatening events. If separation happens, it might cause embolization (blocking blood flow to vital organs), vessel injury, or severe bleeding.
Healthcare professionals using the recalled Flexor Check-Flo Introducers for vascular procedures are at risk. Patients undergoing procedures with these devices could face serious complications if separation occurs.
Check for the specific lot numbers listed in the recall: 13197465, 13203168, 13203169, 13205344, 13205348, 13229675, 13229688, 13265333, 13268039, 13281806, 13310762, 13318041, 13329229, 13329233, 13342873, 13349039, 13354264, 13357260, 13372472, 13398839, 13441228, NS13186257, NS13186258, NS13246550, NS13260027, NS13304448, NS13329255, NS13329256, NS13333102, NS13354273, NS13354274, NS13360443, NS13360444, NS13388330, NS13401851. The product is used in vascular procedures by medical professionals.
Discontinue use of the recalled Flexor Check-Flo Introducers if you have them.
The recalled model is Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC with Order Number G56222.
The lot numbers are: 13197465, 13203168, 13203169, 13205344, 13205348, 13229675, 13229688, 13265333, 13268039, 13281806, 13310762, 13318041, 13329229, 13329233, 13342873, 13349039, 13354264, 13357260, 13372472, 13398839, 13441228, NS13186257, NS13186258, NS13246550, NS13260027, NS13304448, NS13329255, NS13329256, NS13333102, NS13354273, NS13354274, NS13360443, NS13360444, NS13388330, NS13401851.
If separation occurs, it could result in life-threatening events such as embolization, vessel injury, or hemorrhage.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0604-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0604-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
