FDA Recalls Reprocessed IVUS Catheters Due to Reprocessing Cycle Violation
Northeast Scientific Inc. is recalling 690 reprocessed intravascular ultrasound catheters because they exceed the FDA-approved single reprocessing cycle limit. Devices were distributed nationwide across ten states.
- Product
- NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
- Category
- Medical Device
- Distribution
- Distributed nationwide