Z-0188-2025 Class II Ongoing
FDA device recall Z-0188-2025 was initiated by Smiths Medical ASD, Inc. on September 24, 2024 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 1100 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- September 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1100 units
Product Description
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
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.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 50351688504126 (case), 10351688504128 (pouch), Lot Numbers: 4293125, 4328466, 4277644, 4349995, 4363255