medical Class I Updated 2020-12-30

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC

Recalled Product

Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 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: 13135874, 13141336, 13162743, 13168158, 13192089, 13214454, 13229690, 13237656, 13265339, 13297262, 13312708, 13320587, 13323491, 13342872, 13349041, 13363230, 13382710, 13407498, NS13140914, NS13219558, NS13221811, NS13246568, NS13265338, NS13291878, NS13291879, NS13312707, NS13342874, NS13349040, NS13360428, NS13372495

View official government recall

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