FDAClass IISeptember 8, 2021

smiths medical portex Tracheal Intubation Stylet recall

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Why was smiths medical portex Tracheal Intubation Stylet recalled?

The incorrect device is contained in the package.

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 4015424

Product
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Recalling firm
Smiths Medical ASD Inc.
Quantity
1,590 units
Distribution
International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.
Recall date
September 8, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls