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Terminated

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

FDA Recall Z-2334-2021 · Posted None

Recalling FirmNortheast Scientific Inc.
Recall StatusTerminated
Product CodeOWQ
Date Initiated2021-04-26
Date Terminated2022-03-09
Product Quantity690 devices

Reason for Recall

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

Firm Action

Northeast Science contacted customers by telephone and email on 4/26/21. Customers were asked if inventory remained of the affected lot numbers. Had any of the customers had inventory they would have been instructed to return the products. No inventory was found of the affected lots.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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