FDA-Device2015-11-18Class II

Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.

Teleflex Medical
Hazard

Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.

Sold states
Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador, Denmark, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guyana, Hong Kong, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Martinique, Netherlands, Panama, Peru, Poland, Portugal, Reunion, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Venezuela, and the United Arab Emirates.
Affected count
233,641 units
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0246-2016

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