D-0143-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 5, 2025
- Initiation Date
- October 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 509,360 100 mL bags
Product Description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason for Recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Distribution Pattern
Distributed Nationwide in the USA.
Code Information
Lot # 1029921, Exp Date: 28 February 2027