Z-1732-2019 Class II Terminated
FDA device recall Z-1732-2019 was initiated by Smiths Medical ASD Inc. on February 11, 2019 and is designated Class II. Reason for recall: Packaged with an incorrect size inner cannula. The recall status is terminated (terminated November 2, 2020). Affected quantity: 7,840.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- February 11, 2019
- Termination Date
- November 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,840
Product Description
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 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
Code Information
Item code/product number: 100/856/080 lot number: 3578884