DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have UDI:0366453:000152. 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 their packaging might deform, breaking the sterile seal. This could lead to infection if the device is used without proper sterility. The recall affects specific units with a unique identifier.
The internal packaging (blister pack) might deform when removed from the Tyvek bag. This deformation could compromise the sterile barrier, increasing infection risk if the device is used without proper sterility.
Healthcare professionals using the electrode for brain monitoring or stimulation are most at risk. The recall applies to specific units with the UDI:03664539000152 identifier.
Check for the unique identifier UDI:03664539000152 on the packaging. The device is a smooth electrode 0.8 mm in diameter used for brain monitoring or stimulation.
Inspect the blister pack for signs of deformation before use. If deformed, do not use the device.
The internal packaging (blister pack) might deform when removed from the Tyvek bag, potentially compromising the sterile barrier of the device.
The recall applies to units with the unique identifier UDI:03664539000152.
The official notice does not mention a fix or remedy for this recall.
We’ve drafted a message you can send DIXI Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0539-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0539-2022 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.
