Lead Wire Replacement Parts Recalled for Sheath Damage and Treatment Signal Loss
EBI, LLC is recalling 594 units of 48-inch lead wire replacement parts (part number 1067724-4) due to sheath damage that prevents therapeutic signals from reaching treatment electrodes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall. Although no hospitalizations, injuries, or illnesses have been reported in the source material, this is a risk-of-harm medical device where functional failure could delay or prevent necessary treatment. Meets criteria for Severity 3 (High) per rubric.
Plain-English summary
EBI, LLC is recalling 594 units of 48-inch replacement lead wire assemblies (part number 1067724-4). The recalled devices, identified by UDI-DI 00812301020324, were distributed nationwide in the United States beginning May 1, 2023.
The lead wire sheath (the black cable component) can become damaged, causing the internal wires to be exposed. When this occurs, therapeutic electrical signals cannot reach the electrodes properly, resulting in a loss of the therapeutic signal and potential delay or failure of treatment.
Healthcare facilities and providers using these lead wires should immediately discontinue use and contact EBI, LLC to obtain replacement units. Additional information about this recall is available from the FDA.
The recalled product
- Product
- 48" Lead Wires, Replacement Part Number: 1067724-4
- Manufacturer
- EBI, LLC
- Hazard
- lead-wire-damage
- treatment-signal-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00812301020324 All devices distributed since May 1
- 2023
Distribution
Distributed nationwide across the United States.
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