SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
- Company
- Icu Medical, Inc.
- Recall Initiated
- June 3, 2025
- Posted
- July 11, 2025
- Recall Number
- Z-2116-2025
- Quantity
- 1,445,600
- Firm Location
- Amanecer San Clemente, CA
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
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.
Lot / Code Info
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).
Root Cause
Process control
Action Taken
On 6/3/2025, correction notices were mailed and emailed to customers who were asked to do the following: 1) Inform all potential users of the product in your organization of this notification. 2) Discard the affected devices following your institution's process for discarding product. If discarding the device is not immediately possible at your facility, the device should be quarantined until disposal is possible. 3) Complete and return the Customer Response Form to icumedical2818@sedgwick.com 5. DISTRIBUTORS: If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedical2818@sedgwick.com. For further inquiries, please contact firm at the following: Global Complaint Management, globalcomplaints@icumed.com,1-(866)-216-8806; Customer Service, customerservice@icumed.com, 1-(800)-258-5361; Field Action Processing, icumedical2818@sedgwick.com, 1-(866)-328-0114