0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Recall Number: D-0143-2026

Firm: Otsuka ICU Medical LLC

Classification: Class II

Status: Ongoing

Report Date: 20251105

Initiation Date: 20251027

Termination Date:

Reason for Recall

Lack of Assurance of Sterility: Potential for flexible container leaks.

Product Description

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37