Z-0358-2026Class 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

Product quantity

2450 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 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

Code / lot info

Lot:14393168, 14414091; Distributed in Canada

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 →