ICU Medical Inc recalls 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 0409-79
Recalled November 14, 2018 · FDA recall D-0216-2019 · ICU Medical
Hazard
Lack of Assurance of Sterility; bags have the potential to leak · FDA Class II
Units
2,580,448 bags
Sold at
Nationwide.
Description
Lack of Assurance of Sterility; bags have the potential to leak
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
Manufacturer(s)
ICU Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →