0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., L...
FDA Recall #D-0062-2023 — Class II — November 9, 2022
Product Description
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 for Recall
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Recalling Firm
ICU Medical Inc — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
137,120 bags
Distribution
Nationwide in the USA
Code Information
Lot: 5829936, Exp. MAR 31 2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated