Blood Sample Pressure Kit Recalled for Monitoring Defects
Smiths Medical recalls the medex TranStar KIDS KIT blood sample kit due to manufacturing defects in the pressure transducer that may cause inaccurate or interrupted pressure monitoring, or prevent proper device calibration.
What this means for you
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 a risk-of-harm product where injury has not yet been reported. A defect affecting pressure monitoring in a pediatric blood sample kit represents a potential clinical hazard, though no illnesses or injuries are mentioned in the recall notice.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex TranStar KIDS KIT—a 10-inch closed blood sample kit with integrated pressure monitoring designed for pediatric patients. The product includes a 30cc/hr flush device and disposable pressure transducer.
The recall involves 3,490 units with worldwide distribution. A manufacturing defect in the disposable pressure transducer or its internal chip can cause leaks or component failures that compromise device function.
As a result of these defects, users may experience inaccurate pressure readings, interruptions in pressure monitoring during use, or inability to properly zero (calibrate) the device. The affected lot numbers are 4221225, 4250996, 4297929, 4304897, 4316671, 4323138, 4328494, 4387189, and 4404713.
The recalled product
- Product
- medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- measurement-error
- monitoring-failure
- calibration-failure
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 (11)
- UDI/DI 50351688503006 (case)
- 10351688503008 (pouch)
- Lot Numbers: 4221225
- 4250996
- 4297929
- 4304897
- 4316671
- 4323138
- 4328494
- 4387189
- 4404713
Distribution
Distribution scope not specified by the agency.
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