FDA-Device2014-07-02Class II

RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Teleflex Medical
Hazard

Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.

Sold states
Nationwide Distribution and the country of Colombia.
Affected count
1658 ea
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1851-2014

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