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Recall Observatory FDA recall evidence

Device product

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.

Z-1732-2019

February 11, 2019

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 82387
Status
Terminated
Classification
Class II
Quantity
7,840
Official record key
device-enforcement:Z-1732-2019

Official wording

Reason: Packaged with an incorrect size inner cannula.

Code information: Item code/product number: 100/856/080 lot number: 3578884

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Packaged with an incorrect size inner cannula.