Class I Recall of Willy Rusch Tracheostomy Tube Set by TeleFlex Medical

PUBLISHED: Oct 21, 2016

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

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.

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.

Read the MedWatch safety alert, including a link to the recall notice for additional information.

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