DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have specific UDI codes. Consumers should contact for details.
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 Electro: a small brain electrode that could become contaminated if the packaging deforms. This is a safety issue for medical procedures where sterility is critical.
The electrode's sterile packaging could be compromised if the blister pack deforms, potentially allowing contamination. This could lead to infections during medical procedures where sterility is critical.
Healthcare professionals using the electrode for brain monitoring or stimulation procedures. Patients undergoing such treatments are at risk if the electrode becomes contaminated.
Check for the unique identifier (UDI) on the packaging: 03664539000015. The product is a small, smooth electrode used for brain monitoring.
Reach out to DIXI Medical for specific instructions on handling the recalled product.
The recall is for potential packaging deformation that could compromise sterility, not for use errors.
Contact DIXI Medical directly for specific instructions on handling the recalled product.
Check for the unique identifier (UDI) 03664539000015 on the packaging.
We’ve drafted a message you can send DIXI Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0534-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0534-2022 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.
