Z-0198-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- September 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 units
Product Description
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Reason for Recall
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.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 50351688503082 (case), 10351688503084 (pouch), Lot Numbers: 4226214, 4346067, 4350021, 4359831