Spes Medica recalls Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500…

Recall date

April 8, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1969-2021

FDA classification

Class II

Brand / firm

Spes Medica

Sold / distributed

Distribution in the following US states: CA, MA, and SC.

Why it was recalled

The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.