Device 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.
Z-1969-2021
Product summary
- Firm
- Spes Medica
- Event
- Event 87999
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 boxes
- Official record key
device-enforcement:Z-1969-2021
Official wording
Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Code information: Lot LS20E2538I and 110320C
Distribution pattern: Distribution in the following US states: CA, MA, and SC.
Derived failure modes
-
Unknown
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.