AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
This recall has been terminated (originally issued April 24, 2020).
- Company
- Angiodynamics, Inc.
- Recall Initiated
- April 24, 2020
- Terminated
- September 20, 2022
- Recall Number
- Z-0073-2022
- Quantity
- 37
- Firm Location
- Queensbury, NY
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
lot 5577754
Root Cause
Software Manufacturing/Software Deployment
Action Taken
On April 24, 2020, the firm distributed recall notifications to their consignees, who were all international (non-US). Customers were advised to stop using the recalled product, remove it from inventory, and segregate in a secure location for return. The firm provided further instructions for the return of the product.
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