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.
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 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.
- Hazard
- pressure-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 (9)
- UDI/DI 50351688503013 (case)
- 10351688503015 (pouch)
- Lot Numbers: 4223699
- 4248326
- 4297927
- 4323137
- 4340498
- 4346068
- 4350022
Distribution
Distribution scope not specified by the agency.
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