DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have UDI:0366453:14. Stop using if packaging may be damaged.
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 or contamination during medical use. The recall affects specific units with the UDI code 03664539000114.
The electrode's packaging could deform when removed from the Tyvek bag, potentially breaking the sterile barrier. This might allow contamination or infection during medical procedures. The risk is low but requires careful handling.
Medical professionals using the electrode for brain signal monitoring are most at risk. The recall applies to specific units with the UDI code 03664539000114.
Check for the UDI code 03664539000114 on the packaging. The electrode is a smooth, 0.8 mm diameter device used for brain signal monitoring.
Inspect the packaging for signs of deformation or damage to the sterile barrier.
The packaging could deform, potentially compromising the sterile barrier and increasing infection risk during medical use.
The affected units have the UDI code 03664539000114.
The recall does not provide a fix; users should check packaging integrity and stop using if damaged.
We’ve drafted a message you can send DIXI Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0540-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0540-2022 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.
