FDA Recall
Open, Classified
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Recall: Z-1459-2024
·
Initiated February 26, 2024
Recall
- Recall Number
- Z-1459-2024
- Event Number
- 94134
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- DXN
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 26, 2024
- Posted
- April 1, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
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
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 [email protected].
Distribution
US Nationwide distribution.
Quantity
74,339 units