Z-2199-2025 Class II Ongoing
FDA device recall Z-2199-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on June 16, 2025 and is designated Class II. 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 C… The recall status is ongoing. Affected quantity: 1,427,100 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2025
- Initiation Date
- June 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,427,100 eaches
Product Description
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
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 Pattern
Worldwide distribution - US Nationwide and the countries of Canada and Panama.
Code Information
UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186