Smiths Medical is recalling 241,980 PORTEX Bivona Neonatal, Pediatric, and Adult Tracheostomy Silicone Tubes across multiple product models. The securement flange, which helps hold the tube in place, may tear due to a manufacturing defect. Because no specific remedy was provided in the notification, consumers are advised to contact their healthcare provider or the manufacturer for guidance.
If the securement flange tears, the tracheostomy tube may not stay in the proper position or could become completely displaced from the airway. This can lead to a loss of airway protection or the inability to breathe, which is a critical safety risk for patients relying on these devices.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
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