ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) by Teleflex Medical – Class I Recall: Potential Kinking During Patient Use
AUDIENCE: Risk Manager, Biomedical Engineer
ISSUE: FDA notified healthcare professionals of a Class I Recall of the Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. The affected tracheal tube may kink during patient use. The affected products were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013. See the firm Urgent Medical Device Recall Notification for a list of affected product codes and lot numbers.
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.
BACKGROUND: 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. On January 6, 2014, the firm sent their customers an Urgent Medical Device Recall Notification.
RECOMMENDATION: Immediately discontinue use and quarantine any products with the catalog numbers listed in the Urgent Medical Device Recall Notification. Complete the Recall Acknowledgement Form and fax it to 1-866-804-9881, Attn: Customer Service. 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178