Smiths Medical Issues Urgent Device Recall of Certain Bivona Neonatal, Pediatric, and Flextend Tracheostomy Tubes
MedSun: Newsletter #68, January 2012

Recall - Firm Press Release

Smiths Medical announced that it is initiating a nationwide voluntary recall of Bivona Neonatal, Pediatric and FlexTend Tracheostomy Tubes with integrated connector which is not designed to be used with a disconnect wedge. 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.

Please visit the website below for specific instructions as to what actions consumers who have the Affected Tubes should take.

Additional Information:

Recall – Firm Press Release. Smiths Medical Issues Urgent Device Recall of Certain Bivona Neonatal, Pediatric, and Flextend Tracheostomy Tubes. December 22, 2011.
http://www.fda.gov/Safety/Recalls/ucm285191.htm


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