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.
Reported: July 7, 2021 Initiated: April 8, 2021 #Z-1967-2021
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.
Details
- Recalling Firm
- Spes Medica
- Units Affected
- 20 boxes
- Distribution
- Distribution in the following US states: CA, MA, and SC.
- Location
- Genoa, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spes Medica. Units affected: 20 boxes.
Why was this product recalled? ▼
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Moderate. Recall number: Z-1967-2021.
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