Cap, Device Disinfectant
General Hospital · 21 CFR 880.5440
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
Recent MDR events
21 adverse event reports on file
- CUROS GREEN CAPJul 16, 2026MalfunctionSolventum Us Llc.MW5190742
- 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORSDec 29, 2025Injury3m Company2110898-2025-00077
- CUROS GREEN CAPNov 12, 2025Injury3m CompanyMW5178767
- 3M CUROS CAPNov 12, 2025Malfunction3m CompanyMW5178826
- 3M CUROS PROTECTIVE ALCOHOL CAPSep 10, 2025Malfunction3m CompanyMW5175894
- 3M CUROS PROTECTIVE ALCOHOL CAPSep 10, 2025Malfunction3m CompanyMW5175895
- SWABCAP®, 200-CT. BOXJul 17, 2025MalfunctionIcu Medical, Inc.1713468-2025-00010
- SWABCAP®, 200-CT. BOXJul 17, 2025MalfunctionIcu Medical, Inc.1713468-2025-00011
- SWABCAP®, 200-CT. BOXJul 17, 2025MalfunctionIcu Medical, Inc.1713468-2025-00012
- SWABCAPJul 8, 2025MalfunctionIcu Medical, Inc.MW5172399
Event type breakdown
Recalls
2 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedJul 30, 2025
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL
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.
Z-2199-2025 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedJul 11, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
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.
Z-2116-2025 · View FDA record ↗
Registered firms
60 firms currently registered for this product code
Isomedix Operations, Inc
ONTARIO, CA, US
Sterigenics Us Llc
Gurnee, IL, US
Carefusion 2200, Inc.
Vernon Hills, IL, US
Solventum Poland Manufacturing Sp. Zo.o
Wroclaw Dolnoslaskie, PL
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Excelsior Medical Llc
NEPTUNE, NJ, US
Shanghai Jpy Ion-tech Co., Ltd.
SHANGHAI, CN
Icu Medical, Inc
Salt Lake City, UT, US
Icu Medical, Inc.
SAN CLEMENTE, CA, US
Solventum Us Llc
San Antonio, TX, US
Icu Medical, Inc.
Lake Forest, IL, US
Isomedix Operations Inc.
Sandy, UT, US
Solventum Us Llc
Brookings, SD, US
Merit Medical Canada Ltd.
Markham Ontario, CA
Sterigenics Us Llc
Charlotte, NC, US
Becton Dickinson
FRANKLIN LAKES, NJ, US
Health Line International Corporation
Salt Lake City, UT, US
Solventum Us Llc
Columbia, MO, US
Solventum Us Llc
Eagan, MN, US
510(k) clearances
22 clearances for this product code
- Icu Medical, Inc.Mar 27, 2026
K252006 · OTTO Disinfecting Cap
- 1World Vista MedicalFeb 11, 2026
K251592 · SteriHub Disinfecting Device and Protective Cover
- Cleansite Medical, Inc.Apr 5, 2024
K223914 · ACTIV Cap
- Becton, Dickinson and CompanyNov 9, 2020
K193190 · BD PureHub Disinfecting Cap
- 3M CompanyOct 29, 2020
K200299 · Curos Jet Disinfecting Cap
- Star Mountain Medical, Inc.Apr 20, 2020
K192382 · CapKlenZ
- Icu MedicalMar 6, 2020
K190918 · SwabTip Male Disinfectant Cap
- Catheter Connections, Inc.May 22, 2015
K142806 · DualCap