medical Class I Updated 2020-12-30

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC

Recalled Product

Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 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: 13077814, 13089577, 13105054, 13140910, 13159710, 13162739, 13170661, 13186251, 13192084, 13194969, 13194972, 13200439, 13203160, 13203163, 13203166, 13214447, 13214449, 13217121, 13217122, 13219552, 13223826, 13223829, 13237651, 13276238, 13276245, 13286649, 13357239, 13366218, 13391145, NS13089580, NS13105058, NS13130292, NS13138931, NS13192091, NS13234809, NS13252367, NS13252368, NS13286655, NS13349016, NS13352450, NS13366219, NS13372482, NS13375232, NS13401834, NS13420125

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