Drug product
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
D-0216-2019
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 81199
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,580,448 bags
- Official record key
drug-enforcement:D-0216-2019
Official wording
Reason: Lack of Assurance of Sterility; bags have the potential to leak
Code information: Lots: a) 84-011-JT Exp. December 01, 2019 and 85-014-JT Exp. January 01, 2020; b) 84-015-JT Exp. December 01, 2019; c) 84-016-JT Exp. June 01, 2019; d) 84-005-JT Exp. December 01, 2019 and 84-014-JT Exp. December 01, 2019
Distribution pattern: Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility