FDAClass IIJanuary 18, 2023

COVIDIEN Emprint Ablation Catheter with Thermosphere recall

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

Why was COVIDIEN Emprint Ablation Catheter with Thermosphere recalled?

The product is labeled with the incorrect expiration date.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI/DI (GTIN): 10884521825765, Lot Number: 520200

Product
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Recalling firm
Covidien, LLC
Quantity
21 units
Distribution
Foreign Distribution: Hong Kong
Recall date
January 18, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls