Reported Apr 5, 2023 · Ongoing
Atrium Pneumostat Chest Drain Valve, Part Number 16100
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 · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
- Atrium Pneumostat Chest Drain Valve, Part Number 16100
- Lot codes and dates
- UDI-DI
20650862161001All lots manufactured 3
- years prior to correction initiationLot
- Numbers
453404455900458299464069455901454344448618449703449992449993450923450924451439452012452013452575453404453472454260454344454345454589454803454850454851455359455360455370455898455900455901456447456448456904456905458298458299458300458301458642458643458644458645461545463439463441463442463443463469463586463587464069464103464104464105464669464809465368
- UDI-DI
- Amount recalled
- 3554 cases of 10
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
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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