FDAClass IIFebruary 22, 2017

Maquet Express Dry Seal Suction Chest Drain recall

Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest…

Why was Maquet Express Dry Seal Suction Chest Drain recalled?

Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

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 Number: 242919, 242920

Product
Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest…
Recalling firm
Atrium Medical Corporation
Quantity
681 cases (4086 units)
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
Recall date
February 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls