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Northeast Scientific Inc. recalls NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood ves
Recalled September 1, 2021 · FDA recall Z-2334-2021 · Northeast Scientific
Hazard
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. · FDA Class II
Units
690 devices
Sold at
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
Description
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
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
Manufacturer(s)
Northeast Scientific Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →