PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controll
Summary
The FDA issued a Class II for PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Produ by Smiths Medical ASD Inc.. Reason: 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..
Details
Source
Device Recall
External ID
Z-1993-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
Lot/Code Info: Lot Number 4072715
Quantity Affected: 40 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of PA, MI, MD, FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-14
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smiths Medical ASD Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical ASD Inc. have FDA actions?
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1993-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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