Recall Z-2199-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated June 16, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Codes / lots: UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
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 taken
On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.
Details
- Recall number
- Z-2199-2025
- Initiated
- June 16, 2025
- Posted by FDA
- July 30, 2025
- Product code
- QBP – Cap, Device Disinfectant
- Quantity
- 1,427,100 eaches
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Panama.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL