Spes Medica recalls Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.
Recalled Product
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. 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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