FDA recall Z-1732-2019

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.

Reason for recall

Packaged with an incorrect size inner cannula.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-02-11

Report date

2019-06-12

Termination date

2020-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2019