Medex TranStar pressure monitoring kit recalled for manufacturing defect
Smiths Medical ASD is recalling the medex TRANSTAR MONITORING KIT due to a manufacturing defect that may cause inaccurate pressure readings, monitoring interruption, or inability to zero the device. Affected units have Lot Number 4270117.
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: FDA Class II recall of a pressure monitoring device with a confirmed manufacturing defect that could impair monitoring accuracy and device function. No reported patient injuries, illnesses, or hospitalizations have been documented.
Plain-English summary
Smiths Medical ASD is recalling the medex TRANSTAR MONITORING KIT (Product Code REF MX20103R1) due to a manufacturing defect in the TranStar Disposable Pressure Transducer component.
The manufacturing defect may cause inaccurate pressure monitoring readings, interruption of pressure monitoring, or an inability to zero the device. The defect originates from either a leak within the pressure transducer or from a defect within the transducer chip.
The recall involves 400 units with Lot Number 4270117 distributed worldwide. This is a Class II FDA medical device recall.
The recalled product
- Product
- medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- pressure-reading-error
- monitoring-interruption
- manufacturing-defect
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 50351688551694 (case)
- 10351688551696 (pouch)
- Lot Numbers: 4270117
Distribution
Distribution scope not specified by the agency.
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