Home / Recalls / Medical Devices
Spes Medica recalls Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE50
Recalled July 7, 2021 · FDA recall Z-1967-2021 · Spes Medica
Hazard
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. · FDA Class II
Units
20 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): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. 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 →