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
Product summary
- 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
Packaged with an incorrect size inner cannula.