Dragonfly Laryngeal Surface Electrode recall
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG…
Why was Dragonfly Laryngeal Surface Electrode recalled?
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot LS20E2538I and 110320C
- Product
- Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG…
- Recalling firm
- Spes Medica
- Quantity
- 8 boxes
- Distribution
- Distribution in the following US states: CA, MA, and SC.
- Recall date
- July 7, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)