Known Identifiers & Locations
FEI Numbers
1417592
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0032-2025 |
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
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.
|
2024-08-30 |
Open, Classified
|
View Details
|
| Z-0033-2025 |
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
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.
|
2024-08-30 |
Open, Classified
|
View Details
|
| Z-0034-2025 |
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
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.
|
2024-08-30 |
Open, Classified
|
View Details
|
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