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-1459-2024

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief