NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
FDA Recall Z-1381-2023 · Posted 2023-04-12
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Recalling FirmAngiodynamics, Inc.
Recall StatusOpen, Classified
Product CodeOAB
Date Initiated2023-03-02
Product Quantity10 boxes( 5 probes/box)
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
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
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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