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Particulate Matter in Intravenous Solutions; National Recall


Baxter International Inc. of Deerfield, IL, recalled 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 the 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.

 

When Baxter manufacturing personnel were performing routine maintenance, particulate matter was detected and identified as material from a solution transmission system pump.

 

Products affected by this recall include various sodium chloride solutions, dextrose solutions, and lactated Ringers solutions. 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. Baxter began the customer notification process on March 24, 2015.

 

See the Recall

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See the Medical Law Perspectives March 5, 2015, Blog: Patients Injected with Unsterile Training IV Solution Injured 

 

 

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