ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
FDA Recall #Z-0363-2026 — Class II — September 8, 2025
Product Description
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Reason for Recall
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Recalling Firm
ICU Medical, Inc. — San Clemente, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
134700 units
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.
Code Information
Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated