Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
This recall is currently active, issued April 1, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- February 26, 2024
- Posted
- April 1, 2024
- Recall Number
- Z-1459-2024
- Quantity
- 74,339 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Nonconforming Material/Component
Action Taken
Medline Industries, LP issued a Medical Device Recall notice to its consignees on 02/26/2024 via USPS and email. The notice explained the problem with the device and requested requested destruction of affected product. Distributors or anyone who further distributed or sold the product is directed to notify their customers. Questions: contact the Recall Department at 866-359-1704 or recalls@medline.com.