FDA-Device2014-02-12Class II

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.

Fresenius Medical Care Holdings, Inc.
Hazard

Bicarbonate Jug Adapter distributed prior to 510(k) approval

Sold states
Nationwide Distribution.
Affected count
703 units
Manufactured in
920 Winter St, Waltham, MA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0920-2014

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