Z-2116-2025Class II

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF...

Name: Z-2116-2025 SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF...
Creator: ICU Medical, Inc.
Published: 2025-06-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-06-03 / Open, Classified / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000 on 2025-06-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2116-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-03
Posted: 2025-07-11
Recalling firm: Abbott Medical
Product: SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Product code: QBP Cap, Device Disinfectant
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.
Root cause tag: manufacturing process
FDA 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 [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
Quantity in commerce: 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2116-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2116-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-11

Product code QBP

K130975Class IISwabcap and SwabflushExcelsior Medical Corp. / cleared 2013-12-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)