Sanitation issue forces FDA recall of ventilator suction systems
The U.S. Food and Drug Administration (FDA) announced a recall on Ballard Closed Suction Systems on behalf of manufacturer Avanos Medical. A sanitation issue has rendered many of them unsafe to use, and supply houses and healthcare organizations will need to return them for a replacement.
The devices are used to remove secretions from the airway when patients are on a ventilator to improve the efficiency of the machine. While there have been no reported injuries, due to the high risk of a potentially fatal infection, this recall has been designated a Class I—the most serious type.
What’s being recalled?
Multiple lots of Ballard Closed Suction Systems are subject to this recall, ranging from adult-sized to infant-sized. See the table below for full details:
Next steps
Do not use the affected products listed in the table. Any suction system subject to this recall must be quarantined immediately. Do not attempt to sanitize them yourself, as they still may be dangerous to use.
Customers are asked to fill out a response form, which was sent by Avanos back in March. The company intends to send replacements. For more information, email [email protected] or call 1-800-433-2797.
Avanos and the FDA ask that the recall notice be shared. It can be found by clicking here
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.