Smiths Medical is conducting this recall because some customers have experienced difficulty disconnecting accessories from the connectors of the Affected Tubes. In some cases, the customer was unable to disconnect the accessory or excessive force led to decannulation of the tube, and an emergency tracheostomy tube change was required. If the accessory is correctly connected to the Affected Tubes, then there will be no issue with disconnection. A copy of the customer notification letter, along with pictures to distinguish the affected tubes, is posted on the Smiths Medical website at http://www.smiths-medical.com.
Consumers who have the Affected Tubes should:
1. Identify all affected unused product in inventory and segregate it to a quarantine location.
2. Complete the Confirmation Form located at http://www.smiths-medical.com and return it by Fax to 219-989-7259 or by email to bivona.tr3@smiths-medical.com.
3. Upon receipt of your completed Confirmation Form, Customer Service will contact you with a Return Material Authorization Number (RMA#), and will schedule the shipment of a replacement Bivona® Neonatal, Pediatric and FlexTend™ Tracheostomy Tube. If you are opting to return the product, credit will be issued upon receipt of the returned product.
If an Affected Tube is currently in use with a patient, there is no evidence to suggest that immediate removal of the Tracheostomy Tube is necessary. Please visit Smiths Medical’s website at http://www.smiths-medical.com/education-resources/videos/airway/index.html for a video demonstration on how to properly connect and disconnect accessories from the Affected Tubes.
Details of Affected Devices:
Bivona® Neonatal, Pediatric and FlexTend™ Tracheostomy Tubes
Lot Numbers 1631477 through 1923406
Smiths Medical is notifying its customers through the U.S. mail. Recipients of the Urgent Field Safety Notice who have distributed the Affected Tubes to other persons or facilities should promptly forward a copy of the Urgent Field Safety Notice accordingly.
For questions regarding this Recall, customers should contact:
Smiths Medical Customer Service (Monday – Friday 8am – 8pm CST)
800-258-5361, Option 1
bivona.tr3@smiths-medical.com
Customers should report any issues with the Bivona® Neonatal, Pediatric and FlexTend Tracheostomy Tubes to Smiths Medical’s Complaints Department at 1-866-216-8806.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online at www.fda.gov/MedWatch/report.htm
• Regular Mail; use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm
• Fax 1-800-FDA-0178.
About Smiths Medical
Smiths Medical www.smiths-medical.com is a leading supplier of specialized medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. It is part of Smiths Group www.smiths.com, a global leader in applying advanced technologies for markets in threat and contraband detection, energy, medical devices, communications and engineered components. Smiths Group employs around 22,000 people in more than 50 countries.
Contact:
Smiths Medical
Judith Rossi, 781-792-2539
