The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Willy Rusch – TracheoFlex Tracheostomy Tube Set
- 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
- Devices Recalled in the U.S.: 5 units distributed nationwide
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
Reason for Recall
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.
Who May be Affected
- Health care providers using the Willy Rusch Tracheostomy Tube Set
- All patient groups undergoing procedures involving the Willy Rusch Tracheostomy Tube Set
What to Do
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.
Health care professionals and customers with questions are instructed to contact their local sales representative or Customer Service at 866-246-6990, with any questions related to this recall.
Date Recall Initiated:
August 26, 2016.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.