Medex TranStar Kids Blood Sample Kit Pressure Monitoring Defect Recall
Smiths Medical is recalling medex TranStar Kids blood sample kits due to a manufacturing defect in the pressure transducer that may cause inaccurate or interrupted pressure monitoring.
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 that could impair critical pressure monitoring functions. No illnesses or injuries have been reported, which qualifies this as a risk-of-harm product without reported injury, scoring 3 (High) per the recall severity rubric.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device (Product Code REF MX9545). The recall affects 250 units distributed worldwide.
A manufacturing defect in the pressure transducer may cause inaccurate pressure monitoring, interruption in pressure monitoring, or inability to zero the device. These failures result from either a leak within the transducer or a defect in the transducer chip.
Healthcare facilities and providers should immediately discontinue use of affected kits. The recalled lot number is 4323136. Contact Smiths Medical for replacement or return instructions.
The recalled product
- Product
- medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 250
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 (3)
- UDI/DI 50351688503068 (case)
- 10351688503060 (pouch)
- Lot Numbers: 4323136
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.
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