Z-2116-2025 Class II Ongoing
FDA device recall Z-2116-2025 was initiated by ICU Medical, Inc. on June 3, 2025 and is designated Class II. 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 recall status is ongoing. Affected quantity: 1,445,600.
Recall Details
- Product Type
- Devices
- Report Date
- July 23, 2025
- Initiation Date
- June 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,445,600
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.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of TX, SD, ID, LA, IN, CO, OK, MO, MN, OR, AZ, NC, TN, VA, CA, IL, FL, MA, OH, MD, PA, NJ, NY, WA, GA, UT, MI, MS, AR, AL, NV, KS, IA, WV, HI, KY, NM and the country of CA.
Code Information
REF/UDI-DI/Lot(Expiration): SCXT3-5-2000/10887709097107/14258739(1-Dec-26), 14258743(1-Feb-26), 14258744(1-Dec-26), 14264200(1-Dec-26), 14272241(1-Dec-26), 14272248(1-Dec-26), 14287456(1-Dec-26), 14287459(1-Dec-26), 14287480(1-Dec-26), 14287482(1-Dec-26), 14287485(1-Dec-26), 14294832(1-Dec-26), 14272254(1-Dec-26), 14310313(1-Dec-26), 14310425(1-Dec-26), 14323354(1-Dec-26), 14287475(1-Dec-26), 14294840(1-Dec-26), 14321645(1-Jan-27), 14321652(1-Jan-27), 14331169(1-Jan-27), 14332773(1-Jan-27), 14341732(1-Oct-26), 14294825(1-Jan-27), 14303209(1-Jan-27), 14310308(1-Jan-27), 14355404(1-Jan-27), 14355409(1-Jan-27) SCXT3-2000/20887709079162/14258214(1-Jan-27), 14258206(1-Jan-27), 14258208(1-Feb-27).