SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
This recall is currently active, issued July 30, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- June 16, 2025
- Posted
- July 30, 2025
- Recall Number
- Z-2199-2025
- Quantity
- 1,427,100 eaches
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Panama.
Lot / Code Info
UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
Root Cause
Process control
Action Taken
On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.