0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Recall Number: D-0062-2023

Firm: ICU Medical Inc

Classification: Class II

Status: Ongoing

Report Date: 20221123

Initiation Date: 20221109

Termination Date:

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37