FDA-Device2024-10-16Class II
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Sold states
Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
Affected count
9.608 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2025Don't want to check this manually?
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