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Northeast Scientific Inc. Recall 88345

Description: 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

Northeast Scientific Inc. Recall 88345 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2334-2021
Event ID88345
Event DescriptionNES 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
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
Quantity690 devices
Recall Reason510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Device Classification20210901
Device Code InfoLots L0017886 through L0020553
Center Classification Date20210823
Recall Initiation Date20210426
Recalling FirmNortheast Scientific Inc.
Initial Notification E-Mail
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