Dragonfly Laryngeal Electrode Recalled Due to Sterilization Process Issues
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization parameters. The affected lots are LS20E2538I and 110320C, distributed to select US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No illnesses or injuries are reported. The recall concerns possible sterilization deviations in an FDA Class II medical device, which constitutes a risk-of-harm product without reported injury.
Plain-English summary
Spes Medica is recalling the Dragonfly Laryngeal Surface Electrode (ET tube size 6.0-7.5 mm, reference numbers LSE3463DCA200 and LSE500DCS-5), which is used for continuous electromyography (EMG) monitoring of the larynx during surgical procedures. The recall affects 8 boxes of product.
The supplier informed the manufacturer of possible deviations in the parameters and processes used for ethylene oxide sterilization. Proper sterilization is essential for medical devices that are used internally during surgical procedures.
The affected product was distributed to medical facilities in California, Massachusetts, and South Carolina under lot numbers LS20E2538I and 110320C.
Healthcare providers and facilities receiving this product should contact Spes Medica for instructions regarding the recalled devices.
The recalled product
- 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.
- Manufacturer
- Spes Medica
- Hazard
- sterilization-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot LS20E2538I and 110320C
Distribution
Distributed in 3 states:
- CA
- MA
- SC
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