DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have specific UDI codes; contact for remedy.
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
DIXI Medical is recalling their Microdeep Depth Electrodes because the internal packaging might deform when removed from the Tyve: this could break the sterile seal. This is a serious risk for medical procedures requiring clean equipment.
The electrode's packaging is designed to stay sterile in a Tyvek bag. If the blister pack deforms during removal, the sterile barrier might be broken, allowing contamination. This could lead to infections or procedure failures.
Healthcare professionals using the electrode for brain monitoring or stimulation are most at risk. Patients receiving these electrodes during procedures could be affected if the packaging deforms.
Check for the UDI code 03664539000039 on the packaging. The product is a smooth electrode 0.8 mm in diameter used for brain monitoring.
Inspect the blister pack for signs of deformation before use. If deformed, do not use the electrode.
The internal packaging could deform when removed from the Tyvek bag, potentially compromising the sterile barrier.
Look for the UDI code 03664539000039 on the packaging. The product is a smooth electrode 0.8 mm in diameter used for brain monitoring.
Check the packaging for deformation. If deformed, do not use it. Contact DIXI Medical for further guidance.
We’ve drafted a message you can send DIXI Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0535-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0535-2022 from DIXI Medical. 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.
