Class II — MEDLINE INDUSTRIES, LP - Northfield
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301 |
| Quantity | 1,427,100 eaches |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Panama. |
| Initiated | 2025-06-16 |
| Classified | 2025-07-30 |
| Recall number | Z-2199-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MEDLINE INDUSTRIES, LP - Northfield (Z-2199-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97169/
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