medical Class II Updated 2021-09-01

Northeast Scientific Inc. recalls NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. F

Recalled 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


Hazard / Issue

510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots L0017886 through L0020553
View official government recall

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