medical Class I Updated 2020-12-30

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC

Recalled Product

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 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

Distribution: Nationwide (United States)

Lot/Code Info: Lot Numbers: 13143101, 13150445, 13159707, 13159715, 13166166, 13168195, 13186332, 13186337, 13214441, 13217127, 13221797, 13223835, 13229666, 13237660, 13246546, 13249446, 13262327, 13265329, 13291866, 13294513, 13307179, 13318024, 13332149, 13332159, 13337780, 13337796, 13346086, 13352434, 13352441, 13354252, 13366190, 13366197, 13382711, 13396125, 13398833, 13398835, 13413758, 13420106

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