FDA recall Z-1967-2021

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-04-08

Report date

2021-07-07

Termination date

2022-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Genoa, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1967-2021