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.
Reported: June 12, 2019 Initiated: February 11, 2019 #Z-1732-2019
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.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 7,840
- 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
- Location
- Minneapolis, MN
Frequently Asked Questions
What product 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.. Recalled by Smiths Medical ASD Inc.. Units affected: 7,840.
Why was this product recalled? ▼
Packaged with an incorrect size inner cannula.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1732-2019.
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