Baxter Voluntarily Recalls Select Lots of IV SolutionsBy
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. The problem was discovered by Baxter manufacturing personnel while performing routine maintenance under which 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.
The lots being recalled were distributed to customers and distributors in the United States and Bermuda between January 14, 2015 and March 5, 2015. Baxter began the customer notification process on March 24, 2015. Customers have been directed not to use products from the recalled lots. The recall applies to eight lots of sodium chloride injection (USP), four lots of dextrose injection (USP), and three lots of lactated ringer’s injection. 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.
Source: Baxter International and FDA