ICU Medical Inc., is recalling one lot of sodium chloride injection after a customer reported seeing particulate matter floating in the solution. The matter was found in a single flexible container of the sodium chloride and was identified as stainless steel, according to a Food and Drug Administration (FDA) recall notice.
Injection of particulate matter could potentially lead to limited adverse events including allergic reactions, local irritation and inflammation in organs and tissues, or other serious adverse events.
The recall affects one lot of 0.9 percent sodium chloride, USP 1000mL, which was manufactured in the U.S. by Hospira, a Pfizer company, on Feb. 1, 2016, and distributed nationwide to Hospira customers between April 14, 2016, and Feb. 2, 2016. The affected product is marked with the NDC 0409-7983-09, Lot # 61-841-FW and expires Jan. 1, 2018. It is in a 1000mL single-dose flexible container.
Sodium chloride injection is used to replace lost body fluids and salts. Other medicines given by injection or by a drip may also be diluted with sodium chloride injection. It can also be used as a sterile irrigation solution.
ICU is notifying distributors and pharmacies of this recall and arranging for a return of all affected products. Consumers who have suffered any adverse events or side effects related to these recalled products should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice