Class II

Medical Device Recall: Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS

MEDLINE INDUSTRIES, LP - Northfield · February 26, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

74,339 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1459-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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