SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
FDA device recall Z-2199-2025 · posted 2025-07-30 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Action taken
- On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- QBP
- Quantity affected
- 1,427,100 eaches
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Panama.
- Date initiated
- 2025-06-16
- Date posted
- 2025-07-30
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SWABCAP AND SWABFLUSH (K130975) | Excelsior Medical Corp. | 2013-12-24 |