PlainRecalls
FDA Devices Moderate Class II Ongoing

medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

Reported: October 30, 2024 Initiated: September 24, 2024 #Z-0195-2025

Product Description

medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

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
1110 units
Distribution
Worldwide distribution.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC. Recalled by Smiths Medical ASD, Inc.. Units affected: 1110 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-0195-2025.