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Bivona Tracheostomy Tubes Investigation
You must read the following notice before sending an e-mail message to Robins Kaplan LLP.
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
Robins Kaplan LLP is Investigating Potential Issues With Certain Smiths Medical Products
Robins Kaplan LLP attorneys are investigating possible concerns with some types of Bivona Tracheostomy Tubes after medical device manufacturer Smiths Medical issued an urgent medical device notification.1 On May 29, 2024, the company sent out an alert to affected customers and distributors that certain specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products might have a defect where the flange, which is the part that helps keep the tube in place, could be torn or broken.2,3
If the product is damaged, the tracheostomy tube may not stay in correct position of the windpipe for patients. This could result in serious problems, including the inability to correctly ventilate or protect the airway. Smiths Medical stated it has received at least 35 reports of serious injuries and one death linked with this issue.4
The U.S. Food and Drug Administration (FDA) has also been notified of the action taken by Smiths Medical.5
Contact Robins Kaplan for an Evaluation of Your Potential Case
If you believe that you have been adversely affected by an issue related to the Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s) the attorneys at Robins Kaplan may be able to help.
If you were not yet contacted by your medical provider, you can see a list of the affected products on ICU Medical’s website. ICU Medical is the parent company of Smiths Medical.6
About Our Mass Tort Attorneys
Robins Kaplan’s mass tort attorneys aren’t afraid to fight for justice for our clients. We have a proven track record of taking on industry giants in various sectors and ensure our clients will not walk alone in their legal journeys. We provide comprehensive guidance through every aspect of their case and help them navigate the complexities of the legal system at every stage. To discuss your potential case with our team, please call 1.800.553.9910 or complete our online contact form above.
1, 2 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-notification-informing-customers-potential-issue-certain
3, 4 https://www.icumed.com/media/la3o0aak/fa2404-01-bivona-cut-flange-customer-letter.pdf
5 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-notification-informing-customers-potential-issue-certain
6 https://www.icumed.com/support/customer-communications-and-clinical-bulletins/bivona/
RELATED PROFESSIONALS
Julie A.K. Reynolds
Associate
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.