Recalled Tracheal Tube Could be Deadly

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.

Teleflex initiated the recall of the "ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet)" in a January 6 letter to U.S. customers. The company is asking all customers to immediately stop using the devices and return all unused ISIS with the following instructions:

  1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed in the Urgent Medical Device Recall Notification.
  2. 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.
  3. 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.

The FDA has classified the recall as Class I.  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.