September 7, 2021

  • ICU Medical has issued a recall for one lot of Aminosyn II 15%, Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to visible particulate matter. The particulates were found to include fibers, hair, and proteinaceous material.
    • There is no impact to members through Benecard Central
    • Aminosyn II is indicated:
      • As a source of nitrogen for short-term nutritional support of certain patients when oral nutrition cannot be tolerated or is undesirable or
      • To prevent or reverse the excretion of more nitrogen than is being taken in by patients who have impaired gastrointestinal absorption of protein and meet certain
    • Administering an intravenous drug that contains particulate matter could cause problems ranging in severity from injection site inflammation to potentially fatal blood clots. ICU Medical had not received any reports of adverse events related to the affected product as of the recall date.
    • ICU Medical is notifying distributors and customers of the recall and advises that hospitals and distributors in possession of the affected Aminosyn II should stop use or further distribution and return it to the place of purchase.
    • Questions regarding the recall can be directed to ICU Medical at 1-844-654-7780. The company recommends that individuals contact their healthcare provider if they have experienced any problems potentially related to use of the recalled Aminosyn II.
    • A full copy of the recall announcement is available on the FDA’s website.
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