Medical device recalls Moderate risk

Teleflex Medical recalls Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a pa…

Recall date
January 13, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1519-2017
FDA classification
Class II
Brand / firm
Teleflex Medical
Sold / distributed
Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and the countries of Canada and Mexico.

Why it was recalled

Labeling error

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

What was recalled

Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx.

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