Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Angiodynamics

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Angiodynamics see related information
Date Initiated by Firm March 02, 2023
Date Posted April 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1381-2023
Recall Event ID 91909
510(K)Number K183385  
Product Classification Low energy direct current thermal ablation system - Product Code OAB
Product NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue.
Catalog Number: 20400111
UPN: H787204001110
Code Information UDI-DI: 15051684029643 Lot Number: 5762110
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact SAME
518-798-1215
Manufacturer 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
FDA Determined
Cause 2		 Under Investigation by firm
Action AngioDynamics issued Urgent Medical Device Recall Letter on March 2, 2023 via Federal Express. Letter states reason for recall health risk and action to take: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location. Segregate this product in a secure location for return to AngioDynamics, Inc. Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. ComplFx Reply Verification Tracking Form: Attn: NK Probe 5-Pack Recall Coordinator Fax number 1-855-273-0519 3. Package and Return the Recalled Product. Package any product that is being returned in an appropriate shipping box. Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: NK Probe 5-Pack Recall Coordinator
Quantity in Commerce 10 boxes( 5 probes/box)
Distribution US Nationwide Distribution: CA,CO, FL, IA, NY, OH
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OAB and Original Applicant = Angiodynamics
-
-