—#209973

Product

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

FDA product code: DXN — System, Measurement, Blood-Pressure, Non-Invasive
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K193627
Affected lot / code info: GTIN 00888277629656, Lot Numbers: L230380005, L230480005, L230580005, L230680005, L230780005, L230980005, L231080005, L231180005, L231280005, L240280005

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 08/30/2024 via email and USPS first class mail. The notice explained the problem, risk to user and requested that units demonstrating the failure be discarded. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. Medline issued a follow up notification to distributors on 09/13/2024. The notification contained the same information as the initial letter, but also instructed distributors to notify customers if the product was further distributed.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.

Timeline

Recall initiated: 2024-08-30
Posted by FDA: 2024-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209973. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.