ICU Medical Inc recalls 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest
Recalled March 31, 2021 · FDA recall D-0313-2021 · ICU Medical
Hazard
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use · FDA Class II
Units
425,628 bottles
Sold at
Distributed Nationwide in the USA to include Puerto Rico
Description
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Product
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
Manufacturer(s)
ICU Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →