← FDA ENFORCEMENT
D-0267-2025Class I

ICU Medical, Inc.

Recalling firm
ICU Medical, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-03-19
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
67,488 flexible containers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.

Product description

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267

Code / lot info

Lot 1023172, Exp Date: 31 January 2026

Other recalls SPEQ maps to Documentation & Change Control
2026-07-22Class IIDaavlin Distributing Company2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIChocolate Bar Holdings LLC
See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. 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.