Baxter International Inc. recalled one lot of 0.9% Sodium Chloride Injection, USP, intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter, and missing port protectors. Baxter was made aware of these issues through customer complaints.
Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. 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, or local irritation and inflammation in tissues and organs.
0.9 % Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. The lot being recalled was distributed to customers and distributors nationwide between January 22, 2015, and February 12, 2015. This recall affects the following lot: Product code 2B1323N, Lot Number C964601.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication