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
    • 3794165
    • SKU 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 5, 2021 · Data as of Sep 19, 6:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.