Particulate Matter in Injection Prompts Class I Recall

A customer complaint of particulate matter identified as iron oxide has prompted ICU Medical Inc. to recall a single lot of lactated Ringer's injection. According to the May 27, 2020, US Food and Drug Administration (FDA) Enforcement Report, the FDA designated the recall Class I, communicating use of the affected product could cause serious adverse health consequences or death. 

“Administration of a drug product that contains metal 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,” stated a May 8, 2020, company announcement. “To date, ICU Medical Inc. has not received reports of adverse events related to this recall.” 

The recall affects lactated Ringer's injection, 1000-mL flexible container (NDC 0409-7953-09), manufactured by Hospira Inc., from lot 07-514-FW (Exp. 7/1/21). The product was distributed throughout the United States by ICU Medical and other distributors.

ICU Medical initiated the voluntary recall May 8, 2020. On May 19, 2020, the FDA classified the recall Class I.

Lactated Ringer's injection is used for parenteral replacement of extracellular losses of fluid and electrolytes.

—Jolynn Tumolo