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.
This recall has been terminated (originally issued July 21, 2020).
- Company
- Neurovision Medical Products Inc
- Recall Initiated
- July 21, 2020
- Terminated
- April 30, 2021
- Recall Number
- Z-2908-2020
- Quantity
- 1,058
- Firm Location
- Ventura, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Kit Lots: 022019A 052919B 053119A 080819A 022519D 081319E 082619A 082719B 021220E 022820C 060120A 110819A 111919F 030519A 030819A 091019B
Root Cause
Under Investigation by firm
Action Taken
Urgent Medical Device Recall Notice, dated July 17, 2020 was sent via email on 7/21/20 and a hard copy via USPS first class mail on 7/28/20-7/29/20 to consignees advising them that Neurovision Medical Products (hereafter NMP) is voluntarily recalling Cobra 1 & 2-Channel EMG Endotracheal Tube, 6 mm, 7 mm, and 8 mm which is used for continuous EMG monitoring and status assessment of the nerves. NMP has initiated this removal due to the potential degradation of the electrode insulation material sooner than the established shelf life. This could make the electrode more susceptible to damage by dental scratching or acute bending. This may interfere with the EMG performance of the device. Failure of the device could result in a delay in the surgical procedure. Malfunction during clinical use should be evident to the clinical user by intermittent or loss of EMG signal and high electrode impedance values. We are aware of one product failure and one complaint associated with the problem. It advises customers to immediately take the following actions: Review the enclosed list of affected lots and product codes. 2. Quarantine product subject to this notice. 3. Cease distribution and use of any product from the affected lots. 4. Advise all applicable departments (including Anesthesia, OR Leadership and Materials Management). 5. Complete and return the enclosed response form as soon as possible: a. Email: customer_service@neurovisionmedical.com b. Fax: (877) 330-1727 6. NMP Customer Service will respond with a return authorization (RMA) number and return shipping label for any stock of affected lots that you may have. 7. If you have distributed this product to another location or entity, notify them of this product recall (include a copy of this notice), and contact NMP Customer Service for a return authorization (RMA). The letter stated the firm is working quickly and closely with their manufacturing team to address the issue. In the meantime, they do have an alt