Baxter IV Sodium Chloride and Potassium Chloride Solutions Recalled due to Particulate Matter
The FDA informs Risk Managers, Nursing and Pharmacy healthcare personnel that four lots of Baxter IV Sodium Chloride and Potassium Chloride Solutions are recalled because they were found to contain particulate matter.
Background of Sodium Chloride and Potassium Chloride Solutions
Sodium Chloride Injection, USP is used as a source of water and electrolytes, a priming solution in hemodialysis procedures, and also as a diluent for reconstitution of a powdered drug product. Potassium Chloride Injection is used as a potassium replacement to support muscle contraction, nerve conduction, and prevention of cardiac arrhythmias.
FDA Alert on Baxter IV Sodium Chloride and Potassium Chloride Solutions
FDA’s reason for the recall is based on customer complaints who identified the appearance of visible particulate matter prior to administration. If the particulate matter is infused, it may cause chronic and acute allergic and inflammatory responses that may be life threatening depending on various conditions like the medical condition of the patient and the size of the particles. The affected products include:
- 0.9% Sodium Chloride 100 mL (Quad Pack)
- 0.9% Sodium Chloride 100 mL MINI-BAG Plus
- 0.9% Sodium Chloride, 50 mL (Single Pack)
- Highly Concentrated Potassium Chloride Injection, 20 mEq/50 mL, VIAFLEX Plus Container
FDA Recommendation on Baxter IV Sodium Chloride and Potassium Chloride Solutions
“Customers are directed not to use products from the recalled lots. Recalled products should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement. Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at [email protected] Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.”
Contacting the FDA to report cases with Baxter IV Sodium Chloride and Potassium Chloride Solutions
In case of detection of adverse events or side effects related to the use of Baxter IV Sodium Chloride and Potassium Chloride Solutions, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:
- The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
- The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
- The completed form can be faxed to: 1-800-FDA-0178
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