Spes Medica recalls Dragonfly Laryngeal Surface Electrodes with specific model numbers due to potential sterilization process deviations. Affected units may not meet safety standards for surgical use.
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 LSE4246MCA075 and LSE500M. These devices were used for larynx monitoring during surgery and may have sterilization issues that could affect safety.
The supplier reported possible deviations in the ethylene oxide sterilization process. This could mean the electrodes were not properly sterilized, increasing the risk of infection or other complications during surgery.
Surgical teams using these electrodes during procedures are most at risk. Patients undergoing surgery with these devices could be affected if the sterilization process was compromised.
Check for model numbers LSE4246MCA075 or LSE500M on the device. The lot number LS20G3274I is also associated with this recall.
Look for model numbers LSE4246MCA075 or LSE500M on the Dragonfly Laryngeal Surface Electrode.
The supplier reported possible deviations in the ethylene oxide sterilization process, which could affect safety standards.
The recall record does not specify a remedy, so check with Spes Medica for further instructions.
The recall indicates potential sterilization issues, but the exact risk level is not clearly stated in the record.
We’ve drafted a message you can send Spes Medica to request your refund or repair — edit it as you like.
Subject: Recall Z-1967-2021 — Spes Medica Spes Medica Hello, I own a Spes Medica that is covered by recall Z-1967-2021 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.
