News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Baxter International, Inc. (BAX) Initiates Global Recall Of Four Lots Of IV Solutions


7/17/2014 11:05:11 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

Baxter Initiates Voluntary Worldwide Recall Of Four Lots Of Iv Solutions Due To The Presence Of Particulate Matter

FOR IMMEDIATE RELEASE - July 14, 2014 Baxter International Inc. announced today it is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level. These products have been found to contain particulate matter identified as cellulosic fibers and/or plastics. Baxter received four complaints over a period of six months from customers whose visual inspection identified the appearance of visible particulate matter prior to administration to a patient.

If infused, adverse health consequences of particulate matter could vary depending on the amount of particulate matter injected into the patient, the size of the particles, the patients underlying medical condition and the presence of a right-to-left cardiac shunt. The presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening. There have been no reported adverse events associated with this issue to date, and an investigation is underway to determine root cause.

Products affected by this recall are found in the table below:
Product Code Description Lot # Expiry Date NDC
2B1302 0.9% Sodium Chloride 100 mL (Quad Pack) P298190 Aug 2014 0338-0049-18
2B0043 0.9% Sodium Chloride 100 mL MINI-BAG Plus P308650 Oct 2014 0338-0553-18
2B1306 0.9% Sodium Chloride, 50 mL (Single Pack) P309187 Oct 2014 0338-0049-41
2B0822 Highly Concentrated Potassium Chloride Injection, 20 mEq/50 mL, VIAFLEX Plus Container P309476 Oct 2014 0338-0703-41

Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes, for use as a priming solution in hemodialysis procedures, and may be used as a diluent for reconstitution of a powdered drug product. Potassium Chloride Injection is an intravenously administered injectable indicated as a potassium replacement to support nerve conduction, muscle contraction and prevention of cardiac arrhythmias. The lots being recalled were distributed worldwide to customers and distributors between February 2013 and June 2014.

Baxter has notified customers, who are being 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 onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

Contact: Consumer: 1-800-422-9837 onebaxter@baxter.com

Media: John OMalley Deborah Spak 224-948-5353 media@baxter.com

Help employers find you! Check out all the jobs and post your resume.



comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES