FDA-Device2024-04-10Class II
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
MEDLINE INDUSTRIES, LP - Northfield
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
Sold states
US Nationwide distribution.
Affected count
74,339 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1459-2024Don't want to check this manually?
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