Spes Medica recalls Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.
Recalled Product
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
Hazard / Issue
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Issued by
FDA
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