SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
FDA Recall Z-2199-2025 · Posted 2025-07-30
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Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeQBP
Date Initiated2025-06-16
Product Quantity1,427,100 eaches
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.
Firm Action
On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada and Panama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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