Flexor Check-Flo Introducer sheath separation recall due to potential life-threatening complications
The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.
- Product
- Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
- Category
- Medical Device
- Distribution
- Distributed nationwide