Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits
Smiths Medical ASD, Inc. is recalling 800 units of medex TranStar KIDS KIT closed blood sample kits due to a manufacturing defect that may cause inaccurate 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: The recall is classified as FDA Class II. The hazard involves a risk of harm (inaccurate monitoring) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 800 units of the medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device (Product Code REF MX9543). The affected lots are 4297925, 4340497, and 4355387. The product was distributed worldwide.
The recall is due to a manufacturing defect in the TranStar Disposable Pressure Transducer or its chip. This defect may result in a leak, leading to inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device.
Users should stop using the affected devices and contact Smiths Medical ASD, Inc. for further instructions.
The recalled product
- Product
- medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 800
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 (5)
- UDI/DI 50351688503099 (case)
- 10351688503091 (pouch)
- Lot Numbers: 4297925
- 4340497
- 4355387
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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