Drug recall
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product…
FDA recall event 86102 · Class II · Neurovision Medical Products Inc
Key facts
| Event ID | 86102 |
|---|---|
| Recall numbers | Z-2900-2020, Z-2901-2020, Z-2902-2020, Z-2903-2020, Z-2904-2020, Z-2905-2020, Z-2906-2020, Z-2907-2020, Z-2908-2020 |
| Recalling firm | Neurovision Medical Products Inc |
| Product type | Devices |
| Products | Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the…, Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the…, Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the…, Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the…, Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal… and 4 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Jul 21, 2020 |
| Report date | Sep 2, 2020 |
| Termination date | Apr 30, 2021 |
| City | Ventura |
| State | CA |
| Country | United States |
| FEI number | 1930870 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: