PlainRecalls
FDA Devices Moderate Class II Terminated

Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.

Reported: February 18, 2015 Initiated: January 9, 2015 #Z-1078-2015

Product Description

Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.

Reason for Recall

Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.

Details

Recalling Firm
Teleflex Medical
Units Affected
300 units
Distribution
Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled?
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.. Recalled by Teleflex Medical. Units affected: 300 units.
Why was this product recalled?
Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1078-2015.