ICU Medical recalls SwabCap disinfecting caps for needle-free connectors due to potential incomplete seals causing alcohol evaporation and inadequate disinfection. Affected products include SwabSleeve and 200-count boxes with specific reference numbers.
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.
ICU Medical is recalling SwabCap disinfecting caps for needle-free connectors because a manufacturing issue may cause the cap to have an incomplete seal. This could lead to isopropyl alcohol evaporating from the sponge, resulting in inadequate disinfection of medical connectors.
The caps may have an incomplete seal between the foil lid and plastic container. This allows isopropyl alcohol to evaporate from the sponge, which can lead to inadequate disinfection of medical connectors.
Healthcare professionals using these caps for medical procedures are most at risk. Patients using the caps for disinfection may be affected if the caps fail to properly disinfect connectors.
Check for SwabSleeve (REF: SCXT3-5-2000) or SwabCap 200-count boxes (REF: SCXT3-2000). The reference numbers include specific expiration dates and lot numbers listed in the recall notice.
Look for reference numbers SCXT3-5-2000 or SCXT3-2000 on the product packaging.
Due to a manufacturing issue, the disinfecting cap may have an incomplete seal between the foil lid and plastic container, which can cause isopropyl alcohol to evaporate and result in inadequate disinfection.
SwabSleeve (REF: SCXT3-5-2000) and SwabCap 200-count boxes (REF: SCXT3-2000) with specific reference numbers and expiration dates listed in the recall notice.
The recall notice does not specify a remedy, so check the product reference numbers and contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2116-2025 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2116-2025 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
