FDAClass IIJuly 7, 2021

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit recall

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

Why was PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 4072715

Product
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an…
Recalling firm
Smiths Medical ASD Inc.
Quantity
40 units
Distribution
US Nationwide distribution in the states of PA, MI, MD, FL.
Recall date
July 7, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls