FDAFDA · Food and drugs·Recall number Z-0184-2025
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Published October 30, 2024 · Recall initiated: September 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- Worldwide distribution.
- Lot
- UDI/DI 50351688509817 (case), 10351688509819 (pouch), Lot Numbers: 4270117
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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