Class II

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

EBI, LLC · March 22, 2024

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

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

594 units (2 lead wires assembly)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1619-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.