Device product
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Z-1459-2024
Product summary
- Event
- Event 94134
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 74,339 units
- Official record key
device-enforcement:Z-1459-2024
Official wording
Reason: The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
Code information: a) MDS4001, UDI/DI 100888277361228, Lot Numbers: 230280001, 230380001, 230680001, 230780001, 230880001; b) MDS4001LA, UDI/DI 100884389106955, Lot Numbers: 230480003, 230780003, 231180003; c) MDS4001PLUS, UDI/DI 100888277362089, Lot Numbers: 230280004, 230480004, 230780004, 231080004
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory