FDAClass IIApril 19, 2023

NanoKnife 5-Probe Procedure Pack 15 cm - Activation. recall

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

Why was NanoKnife 5-Probe Procedure Pack 15 cm - Activation. 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 15051684029643 Lot Number: 5762110

Product
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Recalling firm
Angiodynamics, Inc.
Quantity
10 boxes( 5 probes/box)
Distribution
US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Recall date
April 19, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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