Drug 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
D-0062-2023
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 91113
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 137,120 bags
- Official record key
drug-enforcement:D-0062-2023
Official wording
Reason: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Code information: Lot: 5829936, Exp. MAR 31 2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility