Date Initiated by Firm |
April 24, 2020 |
Create Date |
October 07, 2021 |
Recall Status1 |
Terminated 3 on September 20, 2022 |
Recall Number |
Z-0073-2022 |
Recall Event ID |
88679 |
510(K)Number |
K150089
|
Product Classification |
Low energy direct current thermal ablation system - Product Code OAB
|
Product |
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103 |
Code Information |
lot 5577754 |
Recalling Firm/ Manufacturer |
Angiodynamics, Inc. 603 Queensbury Ave Queensbury NY 12804-7619
|
For Additional Information Contact |
Saleem Cheeks 518-798-1174
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Software Manufacturing/Software Deployment |
Action |
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. |
Quantity in Commerce |
37 |
Distribution |
Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = OAB and Original Applicant = ANGIODYNAMICS, INC.
|