Class II

Medical Device Recall: ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

ICU Medical, Inc. · September 8, 2025

Reason for Recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Distribution

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

States Affected

NATIONWIDE

Quantity Affected

1700 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0352-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.