ICU Medical Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

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Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.

On July 28, 2017, ICU Medical, Inc., a pure-play infusion therapy company located in San Clemente, CA, announced it is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level after a customer complained of particulate matter in a single flexible container. The particulate was identified as stainless steel.

The recalled lot, number 61-841-FW, has an expiration date of Jan. 1, 2018; was manufactured in the United States by Hospira, a Pfizer company, in February 2016; and distributed nationwide between April 14, 2016 and Feb. 2, 2017. According to the company, administering the affected product, which is used to replenish fluids, could lead to allergic reactions, local irritation and inflammation in organs or tissues, or other problems. No adverse events had been reported as of the date of the company’s press release.

The company is advising hospitals and distributors to stop use of the product and return to place of purchase. Adverse events can be reported to FDA via the agency’s website.


Source: FDA