Urgent Notification from Smiths Medical Regarding Potential Concerns with Specific Bivona® Tracheostomy Tubes for Customers
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
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Recall Reason Description
A manufacturing defect may cause the securement flange of certain lots of Bivona Neonatal/Pediatric and Adult Tracheostomy products to tear.
- Company Name:
- Smiths Medical
- Brand Name:
-
Brand Name(s)
- Product Description:
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Product Description
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)
Company Announcement
MINNEAPOLIS, MN. August 19, 2024 – An Urgent Medical Device Notification was released by Smiths Medical on May 29, 2024, to inform customers about a potential safety concern regarding certain Bivona® Tracheostomy Tubes.
A notification letter was sent to all impacted customers and distributors, detailing the risk and providing guidance on how to identify affected devices, along with recommended actions for any that are already in use. This letter, along with a list of affected items, is available on ICU Medical’s website here.
In the notification from May 29, 2024, it was specified that if the flange of the item is either torn or broken, it may result in the tracheostomy tube failing to remain in the correct position within the trachea. This could lead to either tracheostomy displacement or decannulation, both of which may impair ventilation or airway protection and could lead to severe adverse outcomes.
For additional questions, please reach out to Smiths Medical using the contact details shown below.
|
Smiths Medical Contact |
Contact Information |
Areas of Support |
|---|---|---|
| Global Complaint Management | globalcomplaints@icumed.com 1-(866)-216-8806 | For reporting adverse events or product issues |
| Customer Service | Customerservice@icumed.com 1-(800)-259-5361 | For questions related to your product or replacements |
The U.S. Food and Drug Administration (FDA) has been informed of these actions.
Anyone experiencing adverse events or quality issues with this product should report them to the FDA’s MedWatch Adverse Event Reporting program via online, mail, or fax.
- Submit the report Online
- For regular mail or fax: Download form or call 1-800-332-1088 for a reporting form, then fill out and return it to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178