medical Class I Updated 2020-12-30

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC

Recalled Product

Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 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: 13029693, 13029694, 13039738, 13039739, 13094338, 13094339, 13094340, 13094344, 13112923, 13112926, 13112927, 13119643, 13121403, 13124432, 13124433, 13126447, 13126448, 13126462, 13135821, 13135822, 13138934, 13138941, 13143088, 13143089, 13143090, 13145948, 13145949, 13153368, 13155283, 13158193, 13158194, 13158195, 13159695, 13163184, 13172666, 13172667, 13172668, 13189166, 13189167, 13189168, 13189171, 13194980, 13197476, 13197477, 13197478, 13197479, 13197480, 13202941, 13202942, 13202943, 13202944, 13202945, 13202946, 13202947, 13202948, 13202949, 13202950, 13202951, 13202953, 13207444, 13207445, 13207446, 13207447, 13207448, 13207449, 13207450, 13207451, 13207452, 13207453, 13207454, 13207455, 13207456, 13207457, 13207458, 13262315, 13262317, 13262321, 13265318, 13268024, 13268028, 13268030, 13268031, 13276235, 13276239, 13276242, 13279088, 13279105, 13281543, 13281544, 13288125, 13291883, 13301861, 13304456, 13318043, 13323500, 13323501, 13337799, 13337809, 13346109, 13352474, 13354244, 13357252, 13363227, 13366216, 13372480, 13391143, NS13108032
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