FDA (Drugs) recall action 84144
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Presence of Particulate Matter.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
ICU Medical Inc is recalling 0.9% Sodium Chloride Injection USP bags because of the presence of particulate matter in the solution.
ICU Medical is recalling 389,808 bags of Lactated Ringer's Injection due to the presence of particulate matter. The affected product was distributed nationwide.