Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could cause life-threatening events like embolization 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 complications such as embolization or bleeding. This recall affects medical devices used in vascular procedures.
The introducer sheath can separate at the connection point during use. If separation happens, it may lead to life-threatening issues like blocked blood flow to vital organs, vessel damage, or severe bleeding.
Medical professionals using these devices for vascular procedures are most at risk. Patients undergoing procedures with the recalled devices could face serious complications.
Check the lot numbers listed: 13189185, 13194984, 13202958, 13205307, 13207466, 13207473, 13231809, 13234793, 13249454, 13262331, 13268033, 13288117, 13303369, 13303376, 13315174, 13332151, 13337783, 13337797, 13346088, 13346089, 13357215, 13357232, 13360414, 13366236, 13377003, 13401855, NS13357214, NS13366235. The product is a Flexor Check-Flo Introducer with order number G56227.
Immediately stop using the recalled Flexor Check-Flo Introducer if you have it.
The recalled device is the Flexor Check-Flo Introducer with order number G56227 and specific lot numbers listed in the recall.
If separation occurs, it could lead to life-threatening events such as embolization, blocked blood flow to vital organs, vessel injury, or severe bleeding.
Check the lot numbers on your device: 13189185, 13194984, 13202958, 13205307, 13207466, 13207473, 13231809, 13234793, 13249454, 13262331, 13268033, 13288117, 13303369, 13303376, 13315174, 13332151, 13337783, 13337797, 13346088, 13346089, 13357215, 13357232, 13360414, 13366236, 13377003, 13401855, NS13357214, NS13366235.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0605-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0605-2021 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.
