← FDA ENFORCEMENT
Z-0353-2026Class II
ICU Medical, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
ICU Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2025-11-05
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.
Firm state
CA
Product quantity
6450 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Product description
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Code / lot info
UDI:10887709071411/Lot:14386086 14407433
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →