DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have UDI:0366453:000176. 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 recall affects specific units with the UDI code 03664539000176.
The electrode's internal packaging (blister pack) could deform when taken out of the Tyvek bag. This deformation might break the sterile barrier, increasing the risk of infection or contamination during medical procedures.
Medical professionals using the electrode for brain signal monitoring or stimulation are most at risk. The recall applies to specific units with the UDI code 03664539000176.
Check for the UDI code 03664539000176 on the packaging. The product is a smooth electrode 0.8 mm in diameter used for brain signal monitoring.
Inspect the internal blister pack for signs of deformation before use.
The internal packaging could deform when removed from the Tyvek bag, potentially compromising the sterile barrier.
The affected units have the UDI code 03664539000176.
The recall does not mention a fix; users should check packaging condition before use.
We’ve drafted a message you can send DIXI Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0541-2022 — DIXI Medical DIXI Medical Hello, I own a DIXI Medical that is covered by recall Z-0541-2022 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.
