FDA Device recall Z-1619-2024
48" Lead Wires, Replacement Part Number: 1067724-4
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of 48" Lead Wires, Replacement Part Number: 1067724-4 by Ebi, citing 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, an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1619-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-22 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ebi |
| Distribution | US |
Product
48" Lead Wires, Replacement Part Number: 1067724-4
Reason
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
Identifiers
| code_info | UDI-DI: 00812301020324 All devices distributed since May 1, 2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1619-2024%22
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