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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