Medex TranStar Single 84in Kit (Smiths Medical) – Pressure Monitoring (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Smiths Medical ASD, Inc. is recalling medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T due to Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Smiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing. The notice explained the issue, potential risk, and requested the destruction of all affected product. Distributors were directed to forward the notice to their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026