Baxter Initiates Voluntary Recall of Select Lots of IV Solutions due to the Potential Presense of Particulate Matter

Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and patient's underlying medical condition. In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. In high-risk patients this may lead to serious adverse health consequences.

While Baxter manufacturing personnel were performing routine maintenance, particulate matter was detected and identified as material from a solution transmission system pump. There have been no adverse events or product complaints associated with this issue reported to Baxter.

Products affected by this recall are listed in the following table.

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. Dextrose Injection, USP is indicated as a source of water and calories. Lactated Ringer's Injection, USP is indicated as a source of water and electrolytes, or as an alkalinizing agent. The lots being recalled were distributed to customers and distributors in the US and Bermuda between 14 January 2015 and 5 March 2015.

Baxter began the customer notification process on 24 March 2015. This recall is being conducted with the knowledge of the FDA.