Medex TranStar Kids blood sample kit recalled for pressure monitoring failures
Smiths Medical is recalling approximately 3,280 medex TranStar KIDS KIT blood sample devices due to a manufacturing defect causing pressure monitoring failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with a manufacturing defect affecting critical pressure-monitoring function. The defect creates a risk of harm through inaccurate, interrupted, or lost pressure monitoring. No illnesses or injuries are reported. Per the FDA severity rubric, this qualifies as High (3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device (Product Code REF MX9547). The recall affects 3,280 units with worldwide distribution.
A manufacturing defect in the TranStar Disposable Pressure Transducer is the cause of this recall. The defect consists of either a leak within the transducer or a defect in the transducer chip. These defects can cause inaccurate pressure monitoring, interruption of pressure monitoring, or inability to zero (calibrate) the device.
The affected lot numbers are: 4223699, 4248326, 4297927, 4323137, 4340498, 4346068, and 4350022. The devices are identified by the following codes: UDI/DI 50351688503013 at the case level and 10351688503015 at the pouch level.
The recalled product
- Product
- medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 3,280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI/DI 50351688503013 (case)
- 10351688503015 (pouch)
- Lot Numbers: 4223699
- 4248326
- 4297927
- 4323137
- 4340498
- 4346068
- 4350022
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 24 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · pressure monitoring failure
See all →- HighSmiths Medical TranStar Pressure Transducers Recalled Due to Manufacturing Defect
FDA (Devices) · 2024-10-30
- HighMedex TranStar Kids Blood Sample Kit Pressure Monitoring Defect Recall
FDA (Devices) · 2024-10-30
- Highmedex TranStar Pressure Monitoring Kit Recalled for Manufacturing Defect
FDA (Devices) · 2024-10-30
Similar recalls
- HighSmiths Medical blood sampling system recalled for pressure reading errors
FDA (Devices) · 2021-10-20
- HighBlood sampling system sets recalled for pressure reading and measurement errors
FDA (Devices) · 2021-10-20
- HighSmiths Medical blood sampling system recalled for pressure measurement errors
FDA (Devices) · 2021-10-20
- HighSmiths Medical Antishunt Sets Recalled Due to Pressure and Reading Errors
FDA (Devices) · 2021-10-20
- HighICU Medical Recalls Pediatric Pressure Transducer Kits Due to Leak Risk
FDA (Devices) · 2016-09-21
- HighSmiths Medical Recalls Medex High Pressure Stopcocks Due to Leak Risk
FDA (Devices) · 2018-12-05