FDAFDA · Food and drugs·Recall number Z-1459-2024
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Published April 10, 2024 · Recall initiated: February 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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