31.10.2019 17:18:34
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ICU Medical Recalls Certain Injections For Presence Of Particulate Matter
(RTTNews) - ICU Medical Inc. (ICUI) has announced a voluntarily recall of one single lot of Lactated Ringer's Injection, and one single lot of 0.9% Sodium Chloride Injection.
The products are being recalled to the hospital level due to the presence of particulate matter.
Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death.
The Lactated Ringer's Injection and Sodium Chloride Injection are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
The affected product lots, manufactured in the U.S. for ICU Medical by Hospira, a Pfizer company in late 2017 and early 2018.
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