MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
This recall is currently active, issued October 8, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- August 30, 2024
- Posted
- October 8, 2024
- Recall Number
- Z-0033-2025
- Quantity
- 9.608 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
Lot / Code Info
GTIN 00888277704049. Lot Numbers: L230480007, L230880007, L231080007, L231280007, L240380007
Root Cause
Under Investigation by firm
Action Taken
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.