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Health See other Health Articles Title: Worldwide Recall of Potassium, Sodium Chloride IV Solutions Medscape Baxter International Inc has initiated a voluntary recall to the hospital/user level of 3 lots of 0.9% sodium chloride and 1 lot of potassium chloride intravenous (IV) solutions because of the presence of particulate matter, identified as cellulosic fibers and/or plastics. IV sodium chloride is often used for electrolyte and fluid replenishment. Potassium chloride can also be used for electrolyte replacement, among other things. The 4 recalled lots "total approximately 940,000 individual units," Baxter spokesperson John O'Malley told Medscape Medical News. The recalled lots were distributed to customers and distributors in the United States, Chile, Hong Kong, and Singapore, between February 2013 and June 2014. "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," according to a Baxter news release posted on the US Food and Drug Administration (FDA) Web site notes. Table. Recalled Product Information Product Code NDC Lot Expiration Date 0.9% sodium chloride 100 mL (quad pack) 2B1302 0338-0049-18 P298190 August 2014 0.9% sodium chloride 100 mL (mini-bag plus) 2B0043 0338-0553-18 P308650 October 2014 0.9% sodium chloride 50 mL (single pack) 2B1306 0338-0049-41 P309187 October 2014 Highly concentrated potassium chloride injection, 20 mEq/50 mL, (Viaflex Plus container) 2B0822 0338-0703-41 P309476 October 2014 The company says there have been no reported adverse events associated with this issue to date, and an investigation is underway to determine the root cause. "Patient safety is Baxter's priority, and we have issued a voluntary recall to ensure no product from the affected lots remain in the field," O'Malley told Medscape Medical News. Baxter has notified customers of this recall. Customers should stop using any recalled product and arrange for its return. Recalled product may be returned for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between 7 am and 6 pm Central time. Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between 8 am and 5 pm Central time, or email Baxter at onebaxter@baxter.com. To report problems with this or other products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787. Poster Comment: I wonder if most of these saline IV's are necessary. A glass of water taken over a specified period of time might work just as well[ permit greater mobility/exercise. Post Comment Private Reply Ignore Thread
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