Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET recall
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage…
Why was Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET recalled?
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Kit Lots 052219E 052219D 052319A 052919C 053119C 060319A 060619A 060719C 061119A 061419A 061919A 062119A 070119C 071219B 080819B 082719E 091219A 091219B 091319A 091619C 091619D 102519A 110719E 110819B 111219A 111519A 111819B 111919E 112019B 112619C 012920A 020420D 020520B 020620A 020620D 020620G 021020E 021420A 021720D 022020C 022420E 030920C 030920D 031620A 031620B 041620B 051920C 060820E 071719A 071819D 072519A 072519C 080819C 081319A 081919A 082619E 091819B 091919A 091919F 100119A 101019A 101019C 101419D 101719A 110519A 110519B 110519C 110719F 012220A 012220E 012320B 012420D 012820A 012820C 042419A 042519B 042519A 050319A 050619A 050719A 051419C 052119B 082619D 042419A 042519B 042519A 050319A 050619A 050719A 051419C 052119B 082619D 112719G 112719H 120219B 120319B 120619C 051220A 051920A 052620A 052820C 060120C 061120A 061220B 062620B
- Product
- Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage…
- Recalling firm
- Neurovision Medical Products Inc
- Quantity
- 7,250
- 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)