Medical device recalls Moderate risk

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

Recall date
January 9, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1078-2015
FDA classification
Class II
Brand / firm
Teleflex Medical
Sold / distributed
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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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