Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET recall
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage…
Why was Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET recalled?
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Kit Lots 070919A 072619A, 073119A 082019B, 120219D 120319G 120519A 121819E 121919E 122019B 010820D 011520A 011620A 012320D 012420B 030620A 031220E 052120B 062620A 022820A 041620C 062520A
- Product
- Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage…
- Recalling firm
- Neurovision Medical Products Inc
- Quantity
- 1,089
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, SC, SD, TN, TX, WA, WI and the countries of Canada, Dominican Republic, Hong Kong.
- Recall date
- September 2, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)