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Friday, July 18, 2014

Recalls, Market Withdrawals, & Safety Alerts Baxter Initiates Voluntary Worldwide Recall Of Four Lots Of IV Solutions Due To The Presence Of Particulate Matter

Recalls, Market Withdrawals, & Safety Alerts Baxter Initiates Voluntary Worldwide Recall Of Four Lots Of IV Solutions Due To The Presence Of Particulate Matter

John O’Malley
Deborah Spak
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 patient’s 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 CodeDescriptionLot #Expiry DateNDC
2B13020.9% Sodium Chloride 100 mL (Quad Pack)P298190Aug 20140338-0049-18
2B00430.9% Sodium Chloride 100 mL MINI-BAG PlusP308650Oct 20140338-0553-18
2B13060.9% Sodium Chloride, 50 mL (Single Pack)P309187Oct 20140338-0049-41
2B0822Highly Concentrated Potassium Chloride Injection, 20 mEq/50 mL, VIAFLEX Plus ContainerP309476Oct 20140338-0703-41
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 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.

Thursday, May 15, 2014


College of DuPage Faculty in Lombard as Illinois Victims of Heinous Hate...

Mental Health Awareness For Suicidal People in May

During the month of May, Mental Health Awareness Month is a very important issue for all Americans, especially in the Midwestern state of Illinois for Mother’s Day. Eight (8) years ago, my Mother committed suicide by stabbing herself with a brand new, large stainless steel kitchen knife which the bank TCF at Jewel-Osco had given her as a gift for opening a brand new bank account on Main Street, in the Village of Lombard, Du Page County, Illinois USA. When I returned home in the afternoon from the Harold Washington Public Library, I found my Mother face down on the second floor bedroom of our Lombard home. After I turned her to face me, I found the long kitchen knife stuck in her upper abdomen. Quickly I pulled out the knife, and called “911” for the Lombard Fire Department Paramedics and Dr. Thomas who arrived to help my Mother who was still unconscious with a beating pulse. The Lombard Fire Department removed my Mother and I have not seen her again for the last 8 years, after she was staying with me at our Lombard home in Du Page County, Illinois. Prior to the suicidal attempt, my Mother had been hospitalized in the Psychiatric Ward of the Advocate Masonic Medical Center in care of Dr. McKenna and social worker Tilary who discharged her for Thanksgiving, without providing for her the prescribed medications for her mental health condition. My Mother was forcefully committed to psychiatric care at the Masonic Medical Center in the Lakeview neighborhood by Jim Wilbrot and his friends, after they took her widow’s Social Security Disability cash funds for more than $800 which she had in her purse, while visiting in Oak Park, Illinois. The Lombard Police Department, Renaldo, told me to find my Mother at the Du Page County Coroner’s Office on County Farm Road in Wheaton, Illinois. When I got to the Du Page County Morgue, the Deputy Coroner told me that “THERE WAS NO BODY” in the Morgue drawer for my Mother. Afterwards, the Du Page County Clerk Gary King, mailed me a Death Certificate for my Mother—but I never found the body nor did they invite me to the funeral in Du Page County, Illinois. Eight (8) years have passed and I know that Mental Health caused problems for my Mother after she moved to Lilac Town in 1992. My Mother relocated to a Lombard home near Sunset Knolls Park and the Lombard Mental Health Crisis Intervention Center on Finley Road near Washington Boulevard in Lilac Town. My Mother had been previously treated with “Lithium” by Dr. Eduardo Machado at Illinois Masonic Medical Center and Mercy Hospital in Aurora, Illinois, even when Lithium is known to cause blood poisoning and kill patients during the course of medical treatment. Later, Dr. Machado referred my Mother to Chicago Read Health Center where she was abused as a psychiatric patient by another patient on the ward. The Chicago Social Worker Mrs. Gardas who worked for the Illinois Department of Human Services has been following up on my Mother’s extraordinary Mental Health experience as a psychiatric patient in Illinois, USA. My Mother’s Mental Health issues developed during 1978, after she was abused by a Puerto Rican co-worker, while she worked as an employee at Felt-Products Inc., auto gasket manufacturing plant also known as Federal Mogul where my Father worked for 22 years in Skokie, Cook County, Illinois. Several years have passed during my Mother’s Mental Health experience for me and my family, after she travelled to Harrison and Union City, New Jersey where her second brother and other Cuban-American friends remember her life in Santiago de Cuba, and Cuba. Mental Health Awareness Month for Suicidal People in May becomes an essential issue for me as the eldest daughter in my family, especially when the Illinois Psychiatric Association does not allow me to see or meet my Mother who surprisingly is still alive—re-organizing her life as a Loyola University Alumni and a professional senior citizen under psychiatric mental health supervision in the State of Illinois, USA. Du Page County Clerk Gary King and Elmhurst Memorial Medical Center never contacted me to inform me that my Mother was transferred to a Chicago North Shore facility near Loyola University Lake Shore Campus for Rehabilitation and Medical Treatment unbeknown to me, her eldest daughter who was abandoned as a Lombard resident homeowner in the Lilac Town, presuming that my Mother was “dead”—when she was really “unconscious” from a self-inflicted knife wound on the second floor of our Lombard home, 8 years ago. Many psychiatric suicidal people in Chicago, Illinois survive Mental Health issues and resume their lives under the care of psychiatrists, mental health counselors, therapists, social workers, and many other mental health staff. Can you imagine how Mental Health Awareness has affected and distressed my life as the eldest daughter in my family, “presuming my Mother committed suicide” when she is really alive as a senior citizen resuming her second life with other people around her, without her immediate family?