April 01, 2021
ICU Medical Inc is voluntarily recalling 425,628 bottles 0.9% sodium chloride irrigation after a customer found particulate matter in two bottles, according to the March 31, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 0.9% sodium chloride irrigation in 1000-mL semi-rigid bottles (NDC 0990-7138-09) from lots 16-808-4B, 16-803-4B, and 16-809-4B (Exp. 4/1/23). The product was manufactured for ICU Medical and distributed throughout the United States and in Puerto Rico.
ICU Medical initiated the recall March 9, 2021. The FDA designated the recall Class II on March 25, 2021. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Available with a prescription, sodium chloride irrigation is a sterile, nonpyrogenic solution of electrolytes in water intended for irrigation, washing, rinsing, and dilution purposes.