Recall Z-2116-2025 ยท QBP Cap, Device Disinfectant
ICU Medical, Inc.
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
| Date | Jul 11, 2025 (initiated Jun 3, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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 for |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130975 | SWABCAP AND SWABFLUSH Excelsior Medical Corp., Dec 24, 2013 |