PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 1, 2024 Initiated: March 22, 2024 #Z-1619-2024

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

Details

Recalling Firm
EBI, LLC
Units Affected
594 units (2 lead wires assembly)
Distribution
US Nationwide distribution.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
48" Lead Wires, Replacement Part Number: 1067724-4. Recalled by EBI, LLC. Units affected: 594 units (2 lead wires assembly).
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1619-2024.