MEDLINE INDUSTRIES, LP - Northfield: Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS

Hazard

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

Details from the source

Reason for recall: 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 Distribution: US Nationwide distribution. Quantity: 74,339 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.