FDA-Drug2022-11-23Class II

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

ICU Medical Inc
Hazard

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Sold states
Nationwide in the USA
Affected count
137,120 bags
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0062-2023

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