Z-0192-2025 Class II Ongoing
FDA device recall Z-0192-2025 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: 1160168 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Sep 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1160168 units
Product Description
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
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 50351688503990 (case), 10351688503992 (pouch), Lot Numbers: 4277670, 4287645, 4287649, 4299776, 4277696, 4308930, 4299811, 4308934, 4299812, 4323148, 4264943, 4264939, 4277694, 4264950, 4299779, 4308962, 4323175, 4328515, 4299788, 4299789, 4299790, 4299801, 4299802, 4308954, 4308959, 4308963, 4321917, 4308947, 4334499, 4299786, 4355732, 4355735, 4346115, 4299780, 4355730, 4355727, 4334501, 4346096, 4346097, 4346124, 4355733, 4346109, 4355728, 4355740, 4355750, 4355749, 4355746, 4346120, 4355757, 4355753
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0192-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026