Smiths Medical issues tracheostomy tube voluntary recall
Smiths Medical has initiated a nationwide voluntary recall of Bivona Neonatal, Pediatric and FlexTend Tracheostomy Tubes with an integrated connector that is not designed to be used with a disconnect wedge.
The Kent, England-based Smiths Medical is conducting the 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, the FDA stated.
If the accessory is correctly connected to the affected tubes, then there will be no issue with disconnection, the agency added.
A copy of the customer notification letter, along with pictures to identify the affected tubes, is posted here.
The Kent, England-based Smiths Medical is conducting the 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, the FDA stated.
If the accessory is correctly connected to the affected tubes, then there will be no issue with disconnection, the agency added.
A copy of the customer notification letter, along with pictures to identify the affected tubes, is posted here.