medical Class I Updated 2020-12-30

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC

Recalled Product

Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 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: 13101181, 13121311, 13141330, 13153425, 13159709, 13170659, 13175451, 13186259, 13205335, 13205336, 13205337, 13205338, 13205339, 13205340, 13205341, 13214445, 13217109, 13217110, 13219549, 13226821, 13226822, 13226823, 13226824, 13226825, 13262316, 13262318, 13262383, 13262384, 13262385, 13262386, 13262387, 13262388, 13265309, 13265310, 13265311, 13265312, 13265313, 13265314, 13265315, 13265316, 13265317, 13265319, 13265321, 13268016, 13268018, 13268019, 13268020, 13268021, 13268022, 13268023, 13268025, 13268026, 13268027, 13268029, 13276232, 13276234, 13276236, 13276243, 13279089, 13315183, 13346074, 13346097, 13391157, NS13108062

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