CLASS II Device recall · Reported 22 Feb 2017 · FDA Enforcement Report
Maquet Express Dry Seal Suction Ocean Drain recalled by Atrium Medical
Atrium Medical is recalling Maquet Express Dry Seal Suction Ocean Drain, Single W/S Reference: 2002-300, 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
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-1209-2017
- 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 Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 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
Questions about this recall
Is Maquet Express Dry Seal Suction Ocean Drain, Single W/S Reference: 2002-300 recalled?
Yes. Atrium Medical recalled Maquet Express Dry Seal Suction Ocean Drain, Single W/S Reference: 2002-300 on 23 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1209-2017.
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: 243295
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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