medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- September 24, 2024
- Posted
- October 23, 2024
- Recall Number
- Z-0184-2025
- Quantity
- 50 units
- Firm Location
- Minneapolis, MN
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
Worldwide distribution.
Lot / Code Info
UDI/DI 50351688509817 (case), 10351688509819 (pouch), Lot Numbers: 4270117
Root Cause
Process control
Action Taken
Smiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing. The notice explained the issue, potential risk, and requested the destruction of all affected product. Distributors were directed to forward the notice to their customers.
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