FDA-Device2014-12-24Class II

Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.

Teleflex Medical
Hazard

Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.

Sold states
Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
Affected count
14,000 units
Manufactured in
4024 Stirrup Creek Dr, N/A, Durham, NC, United States
Products
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0799-2015

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