FDA Device recall Z-2908-2020
Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring…
- FDA Device
- Class II
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring… by Neurovision Medical Products, citing the electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2908-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-21 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Neurovision Medical Products |
| Distribution | US |
Product
Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.
Reason
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
Identifiers
| code_info | Kit Lots: 022019A 052919B 053119A 080819A 022519D 081319E 082619A 082719B 021220E 022820C 060120A 110819A 111919F 030519A 030819A 091019B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2908-2020%22
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