Reported Feb 22, 2017 · Terminated
Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air…
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 5 Wentworth Dr · Hudson, NH · 03051-4929
Is this the product you have?
- Maquet Express Dry Seal Suction Chest Drain
- Single Collection w/AC Reference4000-100N
- Intended UseTo 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
- Lot codes and dates
- Lot Number
242919242920
- Lot Number
- Amount recalled
- 681 cases (4086 units)
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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