FDA-Drug2021-03-31Class II
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
ICU Medical Inc
Hazard
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Sold states
Distributed Nationwide in the USA to include Puerto Rico
Affected count
425,628 bottles
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0313-2021Don't want to check this manually?
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