Recall Z-0032-2025 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
| Date | Oct 8, 2024 (initiated Aug 30, 2024) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by firm |
| Action | 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. |
| Quantity | 52,521 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Panama and Jamaica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193627 | Automatic Upper Arm Blood Pressure Monitor Dongguan E-Test Technology Co., Ltd., Jul 12, 2020 |