ICU Medical product recalled over sterility concerns

Recall date

October 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7…

Recall number

D-0216-2019

FDA classification

Class II

Brand / firm

ICU Medical Inc

Sold / distributed

Nationwide.

Why it was recalled

Lack of Assurance of Sterility; bags have the potential to leak

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045