Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC
Recalled Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Hazard / Issue
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.
Issued by
FDA
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