Smiths Medical ASD, Inc. Recall 95438
Description: medex Arterial Kit 1/EA, Product Code REF MX7827
Smiths Medical ASD, Inc. Recall 95438 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0187-2025 |
| Event ID | 95438 |
| Event Description | medex Arterial Kit 1/EA, Product Code REF MX7827 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 2232 units |
| Recall 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. |
| Device Classification | 20241030 |
| Device Code Info | UDI/DI 50351688505185 (case), 10351688505187 (pouch), Lot Numbers: 4282733, 4319605, 4340472, 4355338, 4390060, 4411161 |
| Center Classification Date | 20241023 |
| Recall Initiation Date | 20240924 |
| Recalling Firm | Smiths Medical ASD, Inc. |
| Initial Notification | N/A |
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