FDA (Drugs) recall action 80213
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Lack of assurance of sterility: Bags have potential to leak.
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 bags because they may leak, compromising sterility. The recall covers lots distributed nationwide and in Canada.
ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.
ICU Medical is recalling 941,496 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags distributed nationwide and in Canada.