Recall Z-1967-2021— Spes Medica
Class II · Terminated
Class II FDA medical device recall by Spes Medica, initiated 2021-04-08, terminated 2022-05-10. It names one FDA 510(k) clearance: K093373. 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: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization..
- Recalling firm
- Spes Medica
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-08
- Terminated
- 2022-05-10
- Firm location
- Genoa, N/A, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.