FDA: ICU Medical recalls one lot of 0.9% sodium chloride injection, USP 1,000 mL

Editor's note

The Food and Drug Administration (FDA) on July 31 announced the recall by ICU Medical, Inc (San Clemente, California) of one lot of 0.9% sodium chloride injection, USP 1,000 mL.

The recall was issued because of a confirmed customer complaint of particulate matter identified as stainless steel in a 1,000 mL flexible container for IV infusion.

The affected lot−NDC 0409-7983-09, Lot # 61-841-FW− was distributed nationwide to Hospira customers between April 14, 2016, and February 2, 2017. The lot was manufactured on February 1, 2016, and expires January 1, 2018. 

Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.