Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to potential sheath separation causing life-threatening events 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 that may separate during use, risking 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 connection point during use. If separation happens, it can lead to life-threatening issues like blocked blood flow to vital organs, vessel damage, or bleeding.
Healthcare professionals using the recalled Flexor Check-Flo Introducers for vascular procedures are at risk. Patients undergoing these procedures with the affected devices could face serious complications.
Check the lot numbers listed: 13047587, 13089578, 13089579, 13126439, 13138927, 13197460, 13197462, 13203165, 13219551, 13221814, 13276233, 13312697, 13349024, 13380378, NS13094335, NS13226779. The product is identified by the model RPN KCFW-4.0-35-55-RB-HFANL0-HC and order number G56229.
Immediately stop using the recalled Flexor Check-Flo Introducers with the listed lot numbers as they may separate during use, causing life-threatening events.
The model number is RPN KCFW-4.0-35-55-RB-HFANL0-HC with order number G56229.
If separation occurs, it could result in life-threatening events such as vessel injury, hemorrhage, or blocked blood flow to vital organs.
Check the lot numbers listed: 13047587, 13089578, 13089579, 13126439, 13138927, 13197460, 13197462, 13203165, 13219551, 13221814, 13276233, 13312697, 13349024, 13380378, NS13094335, NS13226779.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0591-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0591-2021 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.
