Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use

AUDIENCE: Risk Manager, Surgery

ISSUE: Teleflex is recalling the Willy Rusch Tracheostomy Tube Set due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, it can deprive the patient of adequate ventilation and would require immediate medical intervention including changing the tracheostomy tube and placing a new tube. The use of affected products may cause serious adverse health consequences including oxygen deprivation, brain damage and death.

Lot Numbers: 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491
Product Codes: 120502-000030, 120502-000040, 120502-000050, 120502-000060, 858121-000050, 858121-000060
Manufacturing Dates: June, 2015 to December, 2015
Distribution Dates: July, 2015 to May, 2016

BACKGROUND: A tracheostomy tube is a single-use device that is placed through the patient’s windpipe (trachea) during a surgical procedure called a tracheostomy to create safe airway access and provide a pathway to remove fluid from the trachea and lungs.

RECOMMENDATION: On August 26, 2016, Teleflex Medical sent an "Urgent Field Safety Notice" to all affected customers. The notice asked customers to:

Identify and quarantine any affected devices in your inventory.
Complete and return the Acknowledgement Form.
Mark the according checkbox on the form to indicate if your facility has an affected device.
After completing the form, contact customer service by calling 866-246-6990, who will issue you a return number. Be sure to write this number into the respective field in the Acknowledgement form.
Complete and return "Appendix 1" of the form for all products in your possession and under control, and fax it to 1-855-419-8507, or provide a completed copy to your local Sales Representative.
Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526074.htm