Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter, according to a July 17 FDA press release. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter.
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
This recall affects the following lots:
- 2B1301 - 0.9 % Sodium Chloride Injection, USP, 50 mL VIAFLEX Plastic Container
- 2B0043 - 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG Plus Container
The lots being recalled were distributed to customers and distributors in the United States between October 7, 2014 and July 14, 2015. Baxter is directing customers not to use product from the recalled lots.
Baxter made a recall in April for select lots of IV solutions for the discovery of particulate matter.