September 16, 2019 UPDATE: This recall has been updated to include additional serial numbers.
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.
- Select Sheridan® branded Endotracheal Tubes and Connectors EIF-000361. Product sizes 2.0, 2.5, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0,8.5, 9.0, 9.5 and 10.0 mm are included in this recall.
- Specific Lots:
- Hudson RCI® Sheridan LTS® 4.0, 5.0, 6.0
Hudson RCI® Sheridan/CF® 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10 mm
Hudson RCI® Sheridan® Preformed 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm
Hudson RCI® Sheridan®/HVT® 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0 mm
Hudson RCI® Sheridan®/EZ-ENDO 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm
Hudson RCI® Sheridan® Uncuffed 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
Sheridan/CF Novaplus® 7.0
Sheridan/HVT® Novaplus® 7.0, 7.5, 8.0, 8.5 mm
See a full list of affected devices
- Distribution Dates: October 2016 to July 2019
- Devices Recalled in the U.S.: 7,164,397
- Date Initiated by Firm: May 22, 2019 amended July 30, 2019
Endotracheal tubes (ETT) are devices used for opening a patient’s airway, ventilation, and administering anesthesia. ETTs are used when a patient cannot breathe on their own, often during surgical procedures that use inhaled anesthetic gases.
Reason for Recall
Teleflex Medical is recalling multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Each tracheal tube includes an appropriately sized 15mm connector. Although the connector can be removed, it should not disconnect from the endotracheal tube without significant force.
Use of the affected devices may cause serious adverse health consequences, including disconnection from the breathing circuit which may result in insufficient oxygenation, and death.
Teleflex Medical has received -195 complaints with 208 occurrences in association with the ETT disconnection. This includes four deaths and 18 injuries.
Who May be Affected
- Patients who undergo procedures involving the Sheridan® branded Endotracheal Tubes and Connectors.
- Health care providers, distributors and facilities using the Sheridan® branded Endotracheal Tubes and Connectors.
What to Do
On May 24, 2019, Teleflex Medical issued an Urgent Recall Notification instructing customers to:
- INSPECT your inventory for the affected product codes identified above. If you have affected stock in inventory, immediately discontinue use and quarantine the products.
- NOTIFY Teleflex. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to email@example.com or hand it to your sales representative.
- RETURN the affected product. A customer service representative will contact you with a Return Goods Authorization (RGA) number covering your inventory and provide instructions for the return of products.
For questions or concerns regarding this notification, please call Teleflex Customer Service at 1-866-396-2111.
|Hudson RCI® Sheridan LTS® 4.0 mm||Hudson RCI® Sheridan® Preformed 3.0 mm|
|Hudson RCI® Sheridan LTS® 5.0 mm||Hudson RCI® Sheridan® Preformed 3.5 mm|
|Hudson RCI® Sheridan LTS® 6.0 mm||Hudson RCI® Sheridan® Preformed 4.0 mm|
|Hudson RCI® Sheridan/CF® 3.0 mm||Hudson RCI® Sheridan® Preformed 4.5 mm|
|Hudson RCI® Sheridan/CF® 3.5 mm||Hudson RCI® Sheridan® Preformed 5.0 mm|
|Hudson RCI® Sheridan/CF® 4.0 mm||Hudson RCI® Sheridan® Preformed 5.5 mm|
|Hudson RCI® Sheridan/CF® 4.5 mm||Hudson RCI® Sheridan® Preformed 6.0 mm|
|Hudson RCI® Sheridan/CF® 5.0 mm||Hudson RCI® Sheridan® Preformed 6.5 mm|
|Hudson RCI® Sheridan/CF® 5.5 mm||Hudson RCI® Sheridan® Preformed 7.0 mm|
|Hudson RCI® Sheridan/CF® 6.0 mm||Hudson RCI® Sheridan® Preformed 7.5 mm|
|Hudson RCI® Sheridan/CF® 6.5 mm||Hudson RCI® Sheridan® Preformed 8.0 mm|
|Hudson RCI® Sheridan/CF® 7.0 mm||Hudson RCI® Sheridan® Preformed 8.5 mm|
|Hudson RCI® Sheridan/CF® 7.5 mm||Hudson RCI® Sheridan® Preformed 9.0 mm|
|Hudson RCI® Sheridan/CF® 8.0 mm||Hudson RCI® Sheridan® Uncuffed 2.0 mm|
|Hudson RCI® Sheridan/CF® 8.5 mm||Hudson RCI® Sheridan® Uncuffed 2.5 mm|
|Hudson RCI® Sheridan/CF® 9.0 mm||Hudson RCI® Sheridan® Uncuffed 3.0 mm|
|Hudson RCI® Sheridan/CF® 9.5 mm||Hudson RCI® Sheridan® Uncuffed 3.5 mm|
|Hudson RCI® Sheridan/CF® 10.0 mm||Hudson RCI® Sheridan® Uncuffed 4.0 mm|
|Hudson RCI® Sheridan®/ EZ-ENDO 5.0 mm||Hudson RCI® Sheridan® Uncuffed 4.5 mm|
|Hudson RCI® Sheridan®/EZ-ENDO 5.5 mm||Hudson RCI® Sheridan® Uncuffed 5.0 mm|
|Hudson RCI® Sheridan®/EZ-ENDO 6.0 mm||Hudson RCI® Sheridan® Uncuffed 5.5 mm|
|Hudson RCI® Sheridan®/EZ-ENDO 6.5 mm||Hudson RCI® Sheridan® Uncuffed 6.0 mm|
|Hudson RCI® Sheridan®/EZ-ENDO 7.0 mm||Hudson RCI® Sheridan® Uncuffed 6.5 mm|
|Hudson RCI® Sheridan®/EZ-ENDO 7.5 mm||Hudson RCI® Sheridan® Uncuffed 7.5 mm|
|Hudson RCI® Sheridan®/EZ-ENDO 8.0 mm||Hudson RCI® Sheridan®/HVT® 5.0 mm|
|Hudson RCI® Sheridan®/EZ-ENDO 8.5 mm||Hudson RCI® Sheridan®/HVT® 5.5 mm|
|Hudson RCI® Sheridan®/EZ-ENDO 9.0 mm||Hudson RCI® Sheridan®/HVT® 6.0 mm|
|Sheridan/CF Novaplus® 7.0 mm||Hudson RCI® Sheridan®/HVT® 6.5 mm|
|Sheridan/HVT® Novaplus® 7.0 mm||Hudson RCI® Sheridan®/HVT® 7.0 mm|
|Sheridan/HVT® Novaplus® 7.5 mm||Hudson RCI® Sheridan®/HVT® 7.5 mm|
|Sheridan/HVT® Novaplus® 8.0 mm||Hudson RCI® Sheridan®/HVT® 8.0 mm|
|Sheridan/HVT® Novaplus® 8.5 mm||Hudson RCI® Sheridan®/HVT® 8.5 mm|
|Hudson RCI® Sheridan®/HVT® 9.0 mm|
|Hudson RCI® Sheridan®/HVT® 10.0 mm|
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
- FDA Medical Recall Database Class 1 Recall Hudson RCI Sheridan LTS
- FDA Medical Recall Database Class 1 Recall Hudson RCI Sheridan CF
- FDA Medical Recall Database Class 1 Recall Hudson RCI Sheridan EZENDO
- FDA Medical Recall Database Class 1 Recall Hudson RCI Sheridan Preformed
- FDA Medical Recall Database Class 1 Recall Hudson RCI Sheridan Uncuffed
- FDA Medical Recall Database Class 1 Recall Hudson RCI Sheridan HVT
- FDA Medical Recall Database Class 1 Recall Sheridan/CF Novaplus
- FDA Medical Recall Database Class 1 Recall Sheridan/HTV Novaplus