Spes Medica recalls Dragonfly Laryngeal Surface Electrodes with specific model numbers due to possible issues with ethylene oxide sterilization processes.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes with model numbers LSE3463DCA200 and LSE500DCS-5. This recall is due to potential deviations in the ethylene oxide sterilization process, which could affect the safety of the device during surgical procedures.
The recall is based on supplier reports of possible deviations in the ethylene oxide sterilization process. Ethylene oxide is a chemical used to sterilize medical devices, and deviations could lead to incomplete sterilization, potentially causing infections or other complications during surgery.
Healthcare professionals using these electrodes during surgery are most at risk. Patients undergoing procedures with these specific models may be affected.
Check for the model numbers LSE3463DCA200 or LSE500DCS-5 on the device. The lot numbers LS20E2538I and 110320C are also associated with this recall.
Identify the model number on the device to see if it matches LSE3463DCA200 or LSE500DCS-5.
The supplier reported possible deviations in the ethylene oxide sterilization process, which could affect the device's safety during surgical procedures.
The recall record does not specify a remedy, so contact Spes Medica directly for guidance.
Yes, the lot numbers LS20E2538I and 110320C are associated with this recall.
We’ve drafted a message you can send Spes Medica to request your refund or repair — edit it as you like.
Subject: Recall Z-1969-2021 — Spes Medica Spes Medica Hello, I own a Spes Medica that is covered by recall Z-1969-2021 from Spes Medica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
