medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Reported: October 30, 2024 Initiated: September 24, 2024 #Z-0204-2025
Product Description
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Reason for Recall
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Details
- Recalling Firm
- Smiths Medical ASD, Inc.
- Units Affected
- 1640 units
- Distribution
- Worldwide distribution.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260. Recalled by Smiths Medical ASD, Inc.. Units affected: 1640 units.
Why was this product recalled? ▼
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0204-2025.
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