FDA recall Z-1381-2023

Angiodynamics, Inc. · Class II · device

Product

NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

Reason for recall

Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure

Distribution

US Nationwide Distribution: CA,CO, FL, IA, NY, OH

Key facts

Status: Ongoing
Initiation date: 2023-03-02
Report date: 2023-04-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2023