FDAClass IIFebruary 22, 2017

Atrium PVC 10 Fr Straight Thoracic Catheter Code recall: Labeling Error

Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

Why was Atrium PVC 10 Fr Straight Thoracic Catheter Code recalled?

Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)

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?

All Lot Numbers With Expiration Date Prior To December 2019

Product
Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
Recalling firm
Atrium Medical Corporation
Quantity
1394 cases (10/case)
Distribution
Nationwide
Recall date
February 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls