CLASS II Device recall · Reported 22 Feb 2017 · FDA Enforcement Report

Maquet Ocean Water Seal Chest Drain recalled by Atrium Medical

Atrium Medical is recalling Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100, distributed nationwide in the US. The recall was initiated on 23 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 242897

Quantity recalled27 cases (162 units)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1206-2017
FDA event ID: 75707
Recalling firm: Atrium Medical, Hudson, NH
Classification: Class II
Status: Terminated
Recall initiated: 23 Dec 2016
FDA classified: 15 Feb 2017
Reported: 22 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

23 Dec 2016	Recall initiated by company
15 Feb 2017	Classified by FDA	+54 days
22 Feb 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Where it was distributed

Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Number: 242897

Where was it sold?

Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 75707

This product is part of a recall event; the main page for the event is Maquet Express Dry Seal Suction Ocean Drain recalled by Atrium Medical.

Reported	Class	Recall	Company	Reason	Where
22 Feb 2017	CLASS II	Maquet Express Dry Seal Suction Ocean Drain recalled by Atrium Medical	Atrium Medical	Packaging Defects	Nationwide
22 Feb 2017	CLASS II	Maquet Oasis Dry Suction Water Seal Chest Drain recalled	Atrium Medical	Packaging Defects	Nationwide
22 Feb 2017	CLASS II	Maquet Ocean Water Seal Chest Drain recalled by Atrium Medical	Atrium Medical	Packaging Defects	Nationwide
22 Feb 2017	CLASS II	Maquet Express Dry Seal Suction Oasis Drain recalled by Atrium Medical	Atrium Medical	Packaging Defects	Nationwide
22 Feb 2017	CLASS II	Maquet Express Dry Seal Suction Ocean Drain recalled by Atrium Medical	Atrium Medical	Packaging Defects	Nationwide
22 Feb 2017	CLASS II	Maquet Express Dry Seal Suction Chest Drain recalled by Atrium Medical	Atrium Medical	Packaging Defects	Nationwide

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