Z-2907-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2020
- Initiation Date
- July 21, 2020
- Termination Date
- April 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,425
Product Description
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 musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.
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 Pattern
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.
Code Information
Kit Lots: 021919D 022019B 040119C 040319C 040419A 071019A 010820C 020520C 021020I 021220A 061220A 061720C 120419E 120919B 042319A 072419B 091019A 091619A 091719C 092019A 092419A 050219B 051419B 052819A 060519B 070519A 022019B 022619C 061319B 061419B 072619B 061820C 080919A 081419C 082219A 082619C 052120A 110719A 111919A 121319A 022020B 022420A 031720C 062420C 041020A