20" Lead Wires recall
20" Lead Wires, Replacement Part Number: 1067724-2
Why was 20" Lead Wires recalled?
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
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: 00812301020300 All devices distributed since May 1, 2023
- Product
- 20" Lead Wires, Replacement Part Number: 1067724-2
- Recalling firm
- EBI, LLC
- Quantity
- 829 units (2 lead wires assembly)
- Distribution
- US Nationwide distribution.
- Recall date
- May 1, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)