DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have UDI:0366453:000091. 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 infections or other issues during medical use. The recall affects specific units with the UDI code 03664539000091.
The electrode's packaging could deform when removed from the Tyvek bag, potentially breaking the sterile barrier. This might allow contamination during medical procedures, increasing infection risk.
Healthcare professionals using the electrode for brain monitoring or stimulation are most at risk. The recall applies to specific units with the UDI code 03664539000091.
Check for the UDI code 03664539000091 on the packaging. The product is a smooth electrode used for brain monitoring and stimulation.
Inspect the packaging for signs of deformation or damage to the sterile barrier.
The packaging could deform when removed from the Tyvek bag, potentially compromising the sterile barrier.
The UDI code for affected units is 03664539000091.
Check for the UDI code 03664539000091 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-0538-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0538-2022 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.
