FDA recall Z-1618-2024

Product

20" Lead Wires, Replacement Part Number: 1067724-2

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.

Key facts

Status

Ongoing

Initiation date

2024-03-22

Report date

2024-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1618-2024