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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