Reported Oct 6, 2021 · 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
- Lots
98 of 98 codes
433297433298433974433692433693434040434962435699432585435659435660436107436106437111437530438520439396439891439905440201441182441183441392441184441185441553441554443330443362443849443968445021446022447065448203447066448138448139448618448995448996450275449702449703449992449993450659450467450923450924451439452012452013453085453472452575453404454260454344454345
- Lots
- Amount recalled
- 92,430 units
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 firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
This product could cause temporary or reversible health problems — stop using it.
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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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