FDAClass IIJune 12, 2019

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. recall

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue…

Why was Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. recalled?

Packaged with an incorrect size inner cannula.

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?

Item code/product number: 100/856/080 lot number: 3578884

Product
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue…
Recalling firm
Smiths Medical ASD Inc.
Quantity
7,840
Distribution
Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland
Recall date
June 12, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls