The Food and Drug Administration (FDA) is alerting providers about a voluntary recall of injectable sodium chloride after a customer reported seeing particulate matter in a container of the product, which later was identified as stainless steel.
Sodium chloride is used intravenously to replenish fluid, and particulate matter can lead to allergic reactions, infections, and inflammation of organs or tissues. The affected ICU Medical 0.9 percent sodium chloride injection, lot number 61-841-FW, was manufactured by Hospira on Feb. 1, 2016, and delivered to customers between April 14, 2016, and Feb. 2, 2017.
Though the particulate matter was discovered before use, FDA urges health care professionals to inspect sodium chloride containers before use and discard them if defects are found. FDA advises health care professionals to report adverse reactions or quality problems associated with these injections to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.
Contact Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.