Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could lead to 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, potentially causing life-threatening events such as vessel injury or bleeding. This recall affects medical devices used in vascular procedures.
The introducer sheath may separate at the connection point during use. If separation happens, it could cause bleeding, block blood flow to vital organs, or require emergency intervention to fix the issue.
Healthcare professionals using the recalled Flexor Check-Flo Introducers for vascular procedures are at risk. Patients undergoing these procedures with the affected devices could experience serious complications.
Check the lot numbers listed: 13047588, 13050227, 13050229, 13130291, 13138925, 13203167, 13226780, 13276230, 13315165, 13332154, 13375204, 13375207. The product is sold under the brand name Cook Inc. for vascular procedures.
Immediately stop using the recalled Flexor Check-Flo Introducers with the listed lot numbers as they pose a risk of life-threatening separation.
The recalled device is the Flexor Check-Flo Introducer with model RPN KCFW-4.0-35-55-RB-HFANL1-HC and order number G56234.
The lot numbers are: 13047588, 13050227, 13050229, 13130291, 13138925, 13203167, 13226780, 13276230, 13315165, 13332154, 13375204, 13375207.
If separation occurs, it could lead to life-threatening events such as vessel injury, bleeding, or blockage of blood flow to vital organs.
We’ve drafted a message you can send Cook Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0592-2021 — Cook Inc. Cook Inc. Hello, I own a Cook Inc. that is covered by recall Z-0592-2021 from Cook Inc.. 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.
