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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Industries, LP

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 Class 2 Device Recall Medline Industries, LPsee related information
Date Initiated by FirmAugust 30, 2024
Date PostedOctober 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0033-2025
Recall Event ID 95318
510(K)NumberK193627 
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
ProductMEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Code Information GTIN 00888277704049. Lot Numbers: L230480007, L230880007, L231080007, L231280007, L240380007
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
886-359-1704
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline issued a MEDICAL DEVICE RECALL notice to its consignees on 08/30/2024 via email and USPS first class mail. The notice explained the problem, risk to user and requested that units demonstrating the failure be discarded. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. Medline issued a follow up notification to distributors on 09/13/2024. The notification contained the same information as the initial letter, but also instructed distributors to notify customers if the product was further distributed.
Quantity in Commerce9.608 units
DistributionWorldwide distribution - US Nationwide and the countries of Panama and Jamaica.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXN
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