D-0062-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 23, 2022
- Initiation Date
- November 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 137,120 bags
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 5829936, Exp. MAR 31 2024