The Recall Desk

FDA (Drugs) recall action 81199

ICU Medical Inc recalled 2 products on 2018-11-14

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.

Products
2
Announced
2018-11-14
Critical
0
Units
2,953,360

Why these products were recalled

Lack of Assurance of Sterility; bags have the 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.

1–2 of 2

  • SevereFDA (Drugs)··2018-11-14

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may lack sterility and have the potential to leak.

    Product
    5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-14

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 2,580,448 bags of 0.9% Sodium Chloride Injection because they may leak and lack assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
    Category
    Distribution
    0 states