medical Class I Updated 2020-12-30

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC

Recalled Product

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 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: 13197465, 13203168, 13203169, 13205344, 13205348, 13229675, 13229688, 13265333, 13268039, 13281806, 13310762, 13318041, 13329229, 13329233, 13342873, 13349039, 13354264, 13357260, 13372472, 13398839, 13441228, NS13186257, NS13186258, NS13246550, NS13260027, NS13304448, NS13329255, NS13329256, NS13333102, NS13354273, NS13354274, NS13360443, NS13360444, NS13388330, NS13401851

View official government recall

Were you affected by this recall?

If you were harmed by a recalled product, you may have legal options. Consider speaking with a consumer protection lawyer in your state.

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Get the next US recall alert before it hits the news.

Free. Weekly digest or instant alerts. Unsubscribe anytime.

CAN-SPAM compliant · No spam · Unsubscribe anytime