Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
FDA device recall Z-1459-2024 · posted 2024-04-01 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- DXN
- Quantity affected
- 74,339 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-02-26
- Date posted
- 2024-04-01
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Automatic Upper Arm Blood Pressure Monitor (K193627) | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 |