FDA-Drug2018-11-14Class II

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

ICU Medical Inc
Hazard

Lack of Assurance of Sterility; bags have the potential to leak

Sold states
Nationwide.
Affected count
2,580,448 bags
Manufactured in
600 N FIELD DRIVE, LAKE FOREST, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0216-2019

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