Baxter announced a voluntary recall of two lots of 0.9% Sodium Chloride Injection due to particulate matter found in the solution. The particulate matter was identified as a fragment of the frangible from the vial adapter.
The injection of particulate matter may result in local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization that can result in stroke, heart attack, or damage to other organs such as the kidney or liver. Sodium Chloride Injection is an injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures.
The two affected lots are P317842 and P317891, both with an expiration of May 2015. The affected products are packaged in the 100mL MINI-BAG PLUS Container with product code 2B0043.
Baxter has notified customers not to use product from the recalled lots. Affected products should be returned to Baxter for credit by contacting (888) 229-0001.
For more information call (800) 422-9837 or visit the FDA Safety Alert page.