Class II Recall

ICU Medical Inc

Product
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
Reason
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Classification
Class II
Status
Ongoing
Lot
Lot: 5829936, Exp. MAR 31 2024
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.