—#199181

Product

NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

FDA product code: OAB — Low Energy Direct Current Thermal Ablation System
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K183385
Affected lot / code info: UDI-DI: 15051684029643 Lot Number: 5762110

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

Distribution pattern: US Nationwide Distribution: CA,CO, FL, IA, NY, OH

Timeline

Recall initiated: 2023-03-02
Posted by FDA: 2023-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.