WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) published an announcement drafted by ICU Medical regarding the company’s plan to recall its Lactated Ringer’s Injection voluntarily, USP because of the infiltration of foreign metal particulates in the medication. Giving a patient an injection with a medical contaminated by metal particles could cause numerous adverse health events, including inflammation at the injection site and possible formation of blood clots. The formation of blood clots is a severe medical event that could cause damage to the organs of the patient and could lead to premature death. In the FDA publication, ICU Medical said that the foreign material is iron oxide.
ICU Medical reported that it initiated the recall campaign after one patient complained about a problem with the injection. ICU Medical did not describe the type of complaint it received or how the consumer was alerted to a problem with the injection. ICU Medical reported, however, that it has not received any complaints of injuries or deaths from the injection contaminated with metal particulates. Moreover, ICU Medical did not disclose how the company was able to determine that the metal particulate was iron oxide.
An injection with Lactated Ringer’s, USP, is designed to replace an excess loss of fluids. The injection could be administered with additional calories or without, depending on the needs of the patient.
ICU Medical manufactured the product for a subsidiary company of Pfizer in July of 2019. The company distributed the contaminated injections from September of 2019 to October of 2019. This specific injection may be used for human and veterinary patients.
ICU Medical stated that it began notifying its customers and distributors by letter of the one recalled lot. The company planned to accept all returns and has issued a written notification to hospitals to stop using the contaminated injection immediately.
All adverse incidents concerning the recalled injection must be reported to the FDA and ICU Medical.
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