NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number
Summary
The FDA issued a Class II for NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical by Angiodynamics, Inc.. Reason: Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized b.
Details
Source
Device Recall
External ID
Z-1381-2023
Action Date
2023-04-19
Status
Ongoing
Category
device
Product Description
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Lot/Code Info: UDI-DI: 15051684029643 Lot Number: 5762110
Quantity Affected: 10 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
Distribution
US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-02
Company
Queensbury, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 135 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Angiodynamics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Angiodynamics, Inc. have FDA actions?
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1381-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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