FDA recall Z-2334-2021

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 for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-04-26

Report date

2021-09-01

Termination date

2022-03-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waterbury, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2334-2021