FDAFDA · Food and drugs·Recall number Z-0920-2014
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
Published February 12, 2014 · Recall initiated: December 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Bicarbonate Jug Adapter distributed prior to 510(k) approval
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Nationwide Distribution.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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