Reported Jul 7, 2021 · Terminated

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a…

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?

  • PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit
  • REF 100/596/090 - Product Usageintended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel
Lot codes and dates
  • Lot Number 4072715
Amount recalled
40 units

Where it was sold

Why it was recalled

One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

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 Jun 9, 2023 · Data as of Sep 19, 7:47 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.