Smiths Medical ASD Inc. recalls Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Pr…

Recall date

February 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1732-2019

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

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

Why it was recalled

Packaged with an incorrect size inner cannula.

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

What was recalled

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.