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Class IIOngoingZ-2116-2025

ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve

ICU Medical, Inc.San Clemente, CA, United StatesReported Jul 23, 2025 · 0 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve1 code
  • SCXT3-5-2000
SwabCap, 200-ct. Box1 code
  • SCXT3-2000

Lot / code information

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) — +24 moreShow all
(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)

What the firm is doing

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

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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