FDA Enforcement
Class II
Ongoing
20" Lead Wires, Replacement Part Number: 1067724-2
Recall: Z-1618-2024
·
Reported May 1, 2024
Enforcement
- Recall Number
- Z-1618-2024
- Event ID
- 94291
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- EBI, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 1, 2024
- Initiation Date
- March 22, 2024
- Classification Date
- April 23, 2024
- Address
- 1 Gatehall Dr Ste 303, N/A, Parsippany, NJ, 07054-4514, United States
Description
20" Lead Wires, Replacement Part Number: 1067724-2
Reason
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
Code Info
UDI-DI: 00812301020300 All devices distributed since May 1, 2023
Distribution
US Nationwide distribution.
Quantity
829 units (2 lead wires assembly)