Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes

Recall Class: Class I

Date Recall Initiated: November 28, 2011

Product: Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes with the integrated connector that does not require use of a disconnect wedge (TR3), manufactured from August 29, 2009 to January 29, 2011.

Lot Numbers 1631477 through 1923406 only.

Use: The Bivona Pediatric, Neonatal and Flextend tracheostomy tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. This product is used in health care facilities and home care environment.

Recalling Firm:
Smiths Medical ASD, Inc.
5700 W 23^rd Avenue
Gary, Indiana 46406

Reason for Recall: Some customers have experienced difficulty disconnecting accessories from the connectors of the affected tubes. If excessive force is used to detach the accessory, the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.

Public Contact: Affected customers with questions may contact Smiths Medical Customer Service (Monday – Friday 8am-8pm CST): 1-800-258-5361, Option 1.

FDA District: Detroit

FDA Comments: Smiths Medical mailed all U.S. consignees an Urgent Field Safety Notice on November 28, 2011 and an updated Urgent Field Safety Notice dated Dec 22, 2011 on Janurary 9, 2012. 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.

Smiths Medical has instructed consumers who have the affected tubes to:

1. Identify all affected, unused product in inventory and segregate it to a quarantine location.
2. Complete the Confirmation Form 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 Pediatric Tracheostomy Tubes. If you are opting to return the product, credit will be issued upon receipt of the returned product.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX.