SwabFlush Prefilled Syringe with ICU Medical SwabCaps recall
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Why was SwabFlush Prefilled Syringe with ICU Medical SwabCaps recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
- Product
- SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1,427,100 eaches
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Panama.
- Recall date
- August 6, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)