SwabFlush Prefilled Syringe (Medline) – SwabCap Seal Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
MEDLINE INDUSTRIES, LP Northfield is recalling SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301 due to SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal betwee. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026