Z-0332-2026Class 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

11000 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 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

Code / lot info

UDI:10887709057019/Lot: 14386054

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 →