Class 2 Device Recall Excelsior Medical SwabFlush

• Date Initiated by Firm: June 16, 2025
• Date Posted: July 30, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2199-2025
• Recall Event ID: 97169
• 510(K)Number: K130975
• Product Classification: Cap, device disinfectant - Product Code QBP
• Product: SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
• Code Information: UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield; 3 Lakes Dr; Northfield IL 60093-2753
• Manufacturer Reason for Recall: SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
• FDA Determined Cause: Process control
• Action: On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.
• Quantity in Commerce: 1,427,100 eaches
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Panama.
• 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 = QBP