FDA-Device2015-02-18Class II
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Teleflex Medical
Hazard
Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
Sold states
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.
Affected count
300 units
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2015Don't want to check this manually?
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