DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have UDI:0366453:000138. 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 its 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 recall affects specific units with the UDI code 03664539000138.
The electrode's packaging could deform when taken out of the Tyvek bag, breaking the sterile barrier. This might allow contamination or infection during medical procedures. The risk is low because the deformation is unlikely to happen in normal handling.
Healthcare professionals using the electrode for brain signal monitoring are most at risk. The recall applies to specific units with the UDI code 03664539000138.
Check for the UDI code 03664539000138 on the packaging. The product is a smooth electrode used for brain signal monitoring.
Inspect the internal packaging for signs of deformation before use.
The recall indicates a potential risk if packaging deforms, but the electrode is generally safe if packaging remains intact.
Affected units have the UDI code 03664539000138.
Look for the UDI code 03664539000138 on the packaging. The product is a smooth electrode used for brain signal monitoring.
We’ve drafted a message you can send DIXI Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0542-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0542-2022 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.
