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U.S. Department of Health and Human Services

Class 2 Device Recall Angiodynamics

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 Class 2 Device Recall Angiodynamicssee related information
Date Initiated by FirmMarch 02, 2023
Date PostedApril 12, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1381-2023
Recall Event ID 91909
510(K)NumberK183385 
Product Classification Low energy direct current thermal ablation system - Product Code OAB
ProductNanoKnife 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
FEI Number 1319211
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information ContactSAME
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
ActionAngioDynamics 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 Commerce10 boxes( 5 probes/box)
DistributionUS Nationwide Distribution: CA,CO, FL, IA, NY, OH
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OAB
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