FDAClass IIFebruary 22, 2017

Maquet Express Dry Seal Suction OASIS DRAIN recall

Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or…

Why was Maquet Express Dry Seal Suction OASIS 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: 243312

Product
Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or…
Recalling firm
Atrium Medical Corporation
Quantity
3 cases (18 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