Reported Jul 8, 2020 · Terminated
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- Pediatric Adjustable Flange Tracheostomy Tube Cuffless
- Lot codes and dates
- Model Number60HA30
- Lot
3794165SKU 60HA30
- Amount recalled
- 20 devices
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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