Recall Z-1459-2024 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
MEDLINE INDUSTRIES, LP - Northfield
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
| Date | Apr 1, 2024 (initiated Feb 26, 2024) |
| Status | Open, Classified |
| Reason | The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory |
| Root cause | Nonconforming Material/Component |
| Action | Medline Industries, LP issued a Medical Device Recall notice to its consignees on 02/26/2024 via USPS and email. The notice explained the problem with the device and requested requested destruction of affected product. Distributors or anyone who further distributed or sold the product is directed to notify their customers. Questions: contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity | 74,339 units |
| Distribution | US Nationwide distribution. |
| 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 |