Z-0197-2025 Class II Ongoing
FDA device recall Z-0197-2025 was initiated by Smiths Medical ASD, Inc. on Sep 24, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 800 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Sep 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 800 units
Product Description
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
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 50351688503099 (case), 10351688503091 (pouch), Lot Numbers: 4297925, 4340497, 4355387
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0197-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026