Baxter announced a voluntary recall of 2 lots of 0.9% Sodium Chloride Injection, 250mL Viaflex Plastic Container and 70% Dextrose Injection, 2000mL, due to potential presence of particulate matter.
The recall was prompted after customers complained of insect presence in the products. The particulates were detected prior to patient administration and there have been no adverse events associated with the issue to date. The affected products were distributed in the US between June and December 2015. The lot numbers are C980227 and C985150. Recalled products should be returned to Baxter and unaffected lots are available for replacement.
Injecting a product with particulate matter without in-line filtration can lead to blockage of blood vessels. This can results in stroke, heart attack, or other organ damage (eg: kidney and/or liver). Allergic reactions may be possible, as well as local irritation and inflammation in tissues and organs.
0.9% Sodium Chloride Injection is indicated for intravenous (IV) use as a source of water and electrolytes, and as a priming solution in hemodialysis procedures. Seventy percent Dextrose Injection is indicated for use as a source of calories and water for hydration.
For more information call (800) 422-9837 or visit FDA.gov.