Drug product
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
D-0143-2026
Product summary
- Event
- Event 97841
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 509,360 100 mL bags
- Official record key
drug-enforcement:D-0143-2026
Official wording
Reason: Lack of Assurance of Sterility: Potential for flexible container leaks.
Code information: Lot # 1029921, Exp Date: 28 February 2027
Distribution pattern: Distributed Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility