FDA-Device2021-07-07Class II
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.
Spes Medica
Hazard
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Sold states
Distribution in the following US states: CA, MA, and SC.
Affected count
8 boxes
Manufactured in
Via Buccari 21, N/A, Genoa, N/A, Italy
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1969-2021Don't want to check this manually?
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