Recall Z-2116-2025— ICU Medical, Inc.

Name: FDA recall Z-2116-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-03

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2025-06-03. It names one FDA 510(k) clearance: K130975. Product: SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000. Reason: Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-03
Firm location: San Clemente, CA, 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

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

Reason for recall

Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.

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