Class II
Medical Device Recall: 20" Lead Wires, Replacement Part Number: 1067724-2
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
829 units (2 lead wires assembly)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1618-2024
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.