FDAClass IIDecember 13, 2023

Atrium Firm PVC Thoracic Catheter 36FR Straight recall

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

Why was Atrium Firm PVC Thoracic Catheter 36FR Straight recalled?

A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled 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: 00650862150360, lot ME234686, expiration date 2023-02-24.

Product
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Recalling firm
Atrium Medical Corporation
Quantity
2460 units (246 cases, 10 units/case)
Distribution
US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
Recall date
December 13, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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