FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

AUDIENCE: Risk Manager, Health Professional, Pharmacy, Nursing

ISSUE: Baxter International Inc. announced it is voluntarily recalling two lots of INTRAVIA containers in the U.S. and Canada due to complaints received for particulate matter found inside the fluid path. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition.

BACKGROUND: INTRAVIA containers are empty plastic containers with PVC ports and a sterile fluid path. The recalled lots are INTRAVIA Container, 150 mL Capacity, Lot Number UR13D15112, Product Code 2B8011, distributed to customers between April 26, 2013 and June 20, 2013; and INTRAVIA Container, Empty 500 mL Capacity, Lot Number UR13K14095, Product Code 2B8013, distributed to customers between November 27, 2013 and March 10, 2014. Unaffected lot numbers can continue to be used according to the instructions for use.

RECOMMENDATION: Customers are being directed not to use product from the recalled lots. 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 [email protected]. 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
 
Read the MedWatch safety alert, including links to the Press Release and Product Label at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm420415.htm