Reported Jun 8, 2022 · Terminated
In-Line ventilator adaptor
Baxter Healthcare Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- In-Line ventilator adaptor
- Lot codes and dates
- M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT
- UDI-DI00887761981492. Manufacturing dates February 28, 2020 to present
- Amount recalled
- 259 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Stop using this product now
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
Using this product could cause serious injury, illness or death — stop using it now.
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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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