WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced that Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, addressing potential issues with certain Bivona® Tracheostomy Tubes. This notification aims to inform customers and distributors about the risks associated with these devices.
Affected customers received a detailed letter explaining the hazards and steps to identify affected products. If the flange of the tracheostomy tube is torn or broken, it may lead to the tube not remaining in place within the trachea. Such displacement or decannulation can result in improper ventilation or airway protection, potentially causing severe adverse events. You can find a list of affected products on the ICU Medical website.
Smiths Medical urges customers to verify their products and follow the outlined procedures if they possess affected devices. For any inquiries, customers can contact Smiths Medical’s Global Complaint Management at globalcomplaints@icumed.com or call 1-(866)-216-8806. For questions regarding the product or replacements, contact Customer Service at customerservice@icumed.com or 1-(800)-259-5361.
The FDA encourages reporting of any adverse reactions or quality issues through the MedWatch Adverse Event Reporting program, which is accessible online, via mail, or by fax (1-800-FDA-0178).
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