FDA-Device2019-06-12Class II
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
Smiths Medical ASD Inc.
Hazard
Packaged with an incorrect size inner cannula.
Sold states
Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland
Affected count
7,840
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2019Don't want to check this manually?
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