Reported Feb 12, 2014 · Terminated
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket…
Fresenius Medical Care Holdings, Inc.
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: Fresenius Medical Care Holdings, Inc. · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- Fresenius Bicarbonate Jug Adapter to the 2008
- Series Hemodialysis machine Part Number650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container
- Amount recalled
- 703 units
Where it was sold
- Nationwide
Why it was recalled
Bicarbonate Jug Adapter distributed prior to 510(k) approval
This product could cause temporary or reversible health problems — stop using it.
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