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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmJanuary 03, 2025
Date PostedFebruary 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1173-2025
Recall Event ID 96163
Product Classification General surgery tray - Product Code LRO
ProductMedline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Code Information UDI/DI 10193489736755 (ea) 40193489736756 (cs), Lot Numbers: 22HLA247, 21HLA443, 21JLA520, 22GLA335.
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
FDA Determined
Cause 2		Packaging
ActionMedline issued an URGENT MEDICAL DEVICE RECALL on 01/03/2025 via email and US Mail, first class. The notice explained the issue, the low probability of clinical risk, and requested the consignee perform the following actions: identify and quarantine all affected product and respond to the notice using the website. Those consignees with affected product will receive labels to affix to the package stating not to use the affected component. All those who further distributed or transferred the product were directed to notify those to whom the product was distributed..
Quantity in Commerce36 units
DistributionUS: CA
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.
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