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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 FirmNovember 18, 2024
Date PostedJanuary 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1040-2025
Recall Event ID 96110
510(K)NumberK213481 
Product Classification General surgery tray - Product Code LRO
ProductMedline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Code Information 1) CVI5130: UDI/DI 10653160372349 (each) 00653160372342 (case), Lot Numbers: 2024040490, 2024073190, 2024082790, 2024101790,; 2) STCVC01USGV: UDI/DI 10653160376965 (each) 00653160376968 (case), Lot Numbers: 2024050990.
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		Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email. The notice explained the reason for the recall and requested quarantine of affected products pending correction. The firm requested the completion of the response form, which upon receipt, Medline will send labels to affix to the affected products with the instructions for the consignee to remove the affected component prior to using the kit.
Quantity in Commerce749 units
DistributionUS Nationwide distribution.
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 = LRO
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