DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have UDI: 03664:03664539000053. Stop using if packaging may be deformed.
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 Microdeep Depth Electrodes because the internal packaging might deform when removed from the Tyvek bag, risking a broken sterile barrier. This could lead to infection or contamination during medical use.
The electrode's packaging could deform when taken out of the Tyvek bag, breaking the sterile barrier. This might allow contaminants to enter the device, increasing infection risk during medical procedures.
Healthcare professionals using the electrode for brain signal monitoring or stimulation are most at risk. Patients receiving these electrodes during procedures may also be affected.
Check for the unique identifier (UDI) 03664539000053 on the packaging. The product is sold as a Microdeep Depth Electrode for brain signal monitoring.
Inspect the internal packaging for signs of deformation before use. If deformed, stop using immediately.
The internal packaging could deform when removed from the Tyvek bag, potentially compromising the sterile barrier and increasing infection risk.
The unique identifier (UDI) for affected units is 03664539000053.
Only if the packaging remains intact and undamaged. If the packaging deforms, stop using immediately.
We’ve drafted a message you can send DIXI Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0536-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0536-2022 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.
