Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC
Recalled Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 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
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