FDA announces Ventec vent recall
By HME News Staff
Updated 9:24 AM CDT, Mon March 11, 2024
WASHINGTON – The U.S. Food and Drug Administration has announced a recall of the Ventec Life Systems VOCSN patient breathing package (pediatric, active, oxygen, blue) for a manufacturing issue with its bonded spiral wrap. The recall, a Class I or most serious type of recall, is a correction, not a product removal. The issue: The spiral wrap detaching before or during ventilation, with the potential of compromising the structural integrity and functionality or of causing blockage, stoppage or leaks in the breathing circuit. The FDA says there have been 15 complaints regarding this issue and no reports of injuries or death. Ventec sent all affected customers an urgent medical device recall notification on Jan. 10, 2024, requesting that they stop using the affected package and replace it with a non-affected product; inspect current stock and quarantine any unused affected products to prevent use; and operate the vent as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator.
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