SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Reported: July 23, 2025 Initiated: June 3, 2025 #Z-2116-2025
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.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 1,445,600
- Distribution
- 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.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000. Recalled by ICU Medical, Inc.. Units affected: 1,445,600.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 23, 2025. Severity: Moderate. Recall number: Z-2116-2025.
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