Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Kit Lots: 012320C 012720C 012820B 012920C 013020C 020720D 021020D 021320E 021420B 021420D 021820B 031220A 031620C 041620A 052120C 060820F 061120B 111319C 120219G 120619A 121819B 121919F 122319B 122719A 123019A 072919B 073019A 073119B 010820E 090419A 112619A 101019B 102319B 102819A 102919A 103019A 103119A 111219F 112619G 112719C 120219F 060420A 062920A
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Neurovision Medical Products Inc
- Reason for Recall:
- The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - 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.
Product Codes/Lot Numbers:
Kit Lots: 012320C 012720C 012820B 012920C 013020C 020720D 021020D 021320E 021420B 021420D 021820B 031220A 031620C 041620A 052120C 060820F 061120B 111319C 120219G 120619A 121819B 121919F 122319B 122719A 123019A 072919B 073019A 073119B 010820E 090419A 112619A 101019B 102319B 102819A 102919A 103019A 103119A 111219F 112619G 112719C 120219F 060420A 062920A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2902-2020
Related Recalls
Product packaging contains the wrong part number and kit contents.
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Neurovision Medical Products
mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
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.