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U.S. Department of Health and Human Services

Safety

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Sodium Chloride IV 0.9 Percent by Baxter: Recall - Particulate Matter

Recalled lot number C931923, Product Code 2B1324X

[Posted 08/13/2014]

AUDIENCE: Risk Manager, Pharmacy, Nursing

ISSUE: Baxter International Inc. initiated a voluntary recall of one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, a portion of which was released to customers. The recall is being initiated as a result of particulate matter found near the administration port. There have been no reported adverse events associated with this issue to date, and the root cause of this recall has been identified and resolved. A portion of this lot was distributed to 29 customers in the United States between February 27, 2014, and March 1, 2014; product was packaged in flexible plastic containers. 

If infused, particulate may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

BACKGROUND: Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures.

RECOMMENDATION: Unaffected lot numbers can continue to be used according to the instructions for use.

Baxter has notified customers, who are being directed not to use product from the recalled lot. Recalled product 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 this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[06/24/2014 - Firm Press Release - Baxter International Inc.]