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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot LS20G3274I
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Spes Medica
- Reason for Recall:
- The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot LS20G3274I
Distribution:
Distributed in: US, CA, MA, SC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1967-2021
Related Recalls
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.