Recall Z-2199-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2199-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-16

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-06-16. It names one FDA 510(k) clearance: K130975. Product: SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301. 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-06-16
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K130975 — SWABCAP AND SWABFLUSHExcelsior Medical Corp.·cleared 2013-12-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.