Recall Class: Class I
Date Recall Initiated: January 6, 2014
Product: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet)
See Urgent Medical Device Recall Notification for affected product codes and lot numbers.
The affected products were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013.
Use: A tracheal tube is a device inserted into a patient’s windpipe (trachea) through the nose or mouth and used to maintain an open airway.
2917 Weck Drive
Research Triangle Park, NC 27709
Reason for Recall: The affected tracheal tube may kink during patient use. If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death.
Public Contact: For questions about this recall, customers can call Teleflex Medical at 1-866-804-9881, 8 am to 8 pm, Eastern Time, Monday through Friday.
FDA District: Atlanta District Office
On January 6, 2014, the firm sent their customers an Urgent Medical Device Recall Notification with the following instructions:
- If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed in the Urgent Medical Device Recall Notification.
- To return the product, complete the Recall Acknowledgement Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand to return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of the product to Teleflex Medical.
- If you have no affected product, please complete the Recall Acknowledgement Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of the letter.
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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.