FDA-Drug2025-11-05Class IIPROCESSING DEFECT
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Nationwide distributionDrugs
Hazard
Lack of Assurance of Sterility: Potential for flexible container leaks.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA.
Affected count
509,360 100 mL bags
Manufactured in
3900 Howard Ln, N/A, Austin, TX, United States
Products
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, 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-0143-2026More ICU Medical recalls
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