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Spes Medica recalls Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500D
Recalled July 7, 2021 · FDA recall Z-1969-2021 · Spes Medica
Hazard
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. · FDA Class II
Units
8 boxes
Sold at
Distribution in the following US states: CA, MA, and SC.
Description
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
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.
Manufacturer(s)
Spes Medica
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →