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Member Alert: Baxter Initiates Voluntary Worldwide Recall of 4 Lots of IV Solutions Due to Presence

July 28th, 2014

Baxter International Inc. has announced a voluntarily recall of 4 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 4 complaints over a period of 6 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 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.

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.