Recall Z-0187-2025— Smiths Medical ASD, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2024-09-24. FDA's recall record names no specific 510(k) clearance for this event. Product: medex Arterial Kit 1/EA, Product Code REF MX7827. Reason: 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..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-24
- Firm location
- Minneapolis, MN, United States
Product description
medex Arterial Kit 1/EA, Product Code REF MX7827
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.