Recall Z-2334-2021— Northeast Scientific Inc.

Name: FDA recall Z-2334-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-26

Class II · Terminated

Class II FDA medical device recall by Northeast Scientific Inc., initiated 2021-04-26, terminated 2022-03-09. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles..

Recalling firm: Northeast Scientific Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-26
Terminated: 2022-03-09
Firm location: Waterbury, CT, United States

Product 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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.