SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
FDA Recall Z-2116-2025 · Posted 2025-07-11
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Recalling FirmICU Medical, Inc.
Recall StatusOpen, Classified
Product CodeQBP
Date Initiated2025-06-03
Product Quantity1,445,600
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.
Firm 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 [email protected]
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 [email protected].
For further inquiries, please contact firm at the following: Global Complaint Management, [email protected],1-(866)-216-8806; Customer Service, [email protected], 1-(800)-258-5361; Field Action Processing, [email protected], 1-(866)-328-0114
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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