DIXI Medical Microdeep Depth Electrode packaging defect may compromise sterility
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential deformation of the internal packaging (blister pack) that could compromise the sterile barrier. The recall affects 365 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with potential to compromise sterile barrier due to packaging defect. No illnesses or injuries reported; the hazard is theoretical. Meets rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
DIXI MEDICAL USA is recalling the Microdeep Depth Electrode, a surgical electrode designed for temporary use in recording, monitoring, and stimulating electrical signals at the subsurface level of the brain. The electrode is 0.8 mm in diameter with a rounded tip and multiple platinum/iridium contacts ranging from 16 mm to 80.5 mm in total exploration length.
The recall is due to potential deformation of the internal packaging (blister pack) when removed from the protective Tyvek bag, which could compromise the sterile barrier of the device. The defect affects all lots of the product (UDI: 03664539000138) and involves 365 units that were distributed nationwide in the United States.
Patients and healthcare providers who have received or may use this device should contact their surgeon or medical facility. Healthcare facilities should check their inventory and verify proper storage and handling of affected units to maintain device sterility.
The recalled product
- Product
- The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
- Manufacturer
- DIXI MEDICAL USA
- Hazard
- sterile-barrier-compromise
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots UDI:03664539000138
Distribution
Distributed nationwide across the United States.
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