FDA-Device2024-05-01Class II
48" Lead Wires, Replacement Part Number: 1067724-4
EBI, LLC
Hazard
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
Sold states
US Nationwide distribution.
Affected count
594 units (2 lead wires assembly)
Manufactured in
1 Gatehall Dr Ste 303, N/A, Parsippany, NJ, United States
Products
48" Lead Wires, Replacement Part Number: 1067724-4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1619-2024Don't want to check this manually?
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