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U.S. Department of Health and Human Services

Class 2 Device Recall Automatic Upper Arm Blood Pressure Monitor

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  Class 2 Device Recall Automatic Upper Arm Blood Pressure Monitor see related information
Date Initiated by Firm February 26, 2024
Date Posted April 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-1459-2024
Recall Event ID 94134
510(K)Number K193627  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Code Information a) MDS4001, UDI/DI 100888277361228, Lot Numbers: 230280001, 230380001, 230680001, 230780001, 230880001; b) MDS4001LA, UDI/DI 100884389106955, Lot Numbers: 230480003, 230780003, 231180003; c) MDS4001PLUS, UDI/DI 100888277362089, Lot Numbers: 230280004, 230480004, 230780004, 231080004
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 74,339 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = Dongguan E-Test Technology Co., LTD
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