Baxter International Inc. is voluntarily recalling two lots of INTRAVIA containers in the U.S. and Canada because of complaints received for particulate matter found inside the fluid path, according to the FDA.
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 Nov. 27, 2013 and March 10, 2014.
Unaffected lot numbers can continue to be used according to the instructions for use, according to the release.
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, according to the release.