FDA recall Z-0073-2022

Product

AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

Reason for recall

Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.

Distribution

Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.

Key facts

Status

Terminated

Initiation date

2020-04-24

Report date

2021-10-13

Termination date

2022-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0073-2022