Neurostimulation Kit recall
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the…
Why was Neurostimulation Kit recalled?
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
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: 71005-US: 00812537036137, 00812537033600, 00812537033518, 00812537030975, 00812537030524. 71019-US: 00812537036441, 00812537035604, 00812537035598 Serial Numbers: H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431
- Product
- Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the…
- Recalling firm
- Nalu Medical, Inc.
- Quantity
- 13
- Distribution
- US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
- Recall date
- July 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)