Home / Recalls / EBI, LLC / Z-1619-2024

Z-1619-2024 Class II Ongoing

Recalled by EBI, LLC — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
May 1, 2024
Initiation Date
March 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
594 units (2 lead wires assembly)

Product Description

48" Lead Wires, Replacement Part Number: 1067724-4

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

UDI-DI: 00812301020324 All devices distributed since May 1, 2023

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