Z-1381-2023 Class II Ongoing
FDA device recall Z-1381-2023 was initiated by Angiodynamics, Inc. on March 2, 2023 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 10 boxes( 5 probes/box).
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- March 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 boxes( 5 probes/box)
Product Description
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
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 Pattern
US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Code Information
UDI-DI: 15051684029643 Lot Number: 5762110