FDA recall Z-1459-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-02-26

Report date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1459-2024