Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Reported: July 8, 2020 Initiated: May 26, 2020 #Z-2485-2020
Product Description
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Reason for Recall
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 20 devices
- Distribution
- U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Pediatric Adjustable Flange Tracheostomy Tube Cuffless. Recalled by Smiths Medical ASD Inc.. Units affected: 20 devices.
Why was this product recalled? ▼
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2485-2020.
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