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 products included in the recall are the following:
- 0.9% Sodium Chloride Injection, USP (250mL): Lot# C965038, C965293, C963785, C963884, C963660, C964320, C964486, C964890
- 10% Dextrose Injection, USP (250mL): Lot# C965558, C963520
- 5% Dextrose Injection, USP (250mL): Lot# C963413, C963413A
- Lactated Ringer’s Injection, USP (250mL): Lot# C964619, C964056, C964163
- All products have an expiration date of 7/31/2016
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 United States and Bermuda between January 14, 2015 and March 5, 2015.
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. 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.
Healthcare professionals have been directed not to use products from the recalled lots. Recalled products should be returned to Baxter by contacting Baxter Healthcare Center for Service at 1-888-229-0001.
For more information visit Baxter.com.