Recall Z-2199-2025 ยท QBP Cap, Device Disinfectant
MEDLINE INDUSTRIES, LP - Northfield
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
| Date | Jul 30, 2025 (initiated Jun 16, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On June 16, 2025, the firm notified customers of the affected product. Customers were instructed to destroy the affected product for credit. |
| Quantity | 1,427,100 eaches |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130975 | SWABCAP AND SWABFLUSH Excelsior Medical Corp., Dec 24, 2013 |