Device product
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.
Z-0920-2014
Product summary
- Event
- Event 66953
- Status
- Terminated
- Classification
- Class II
- Quantity
- 703 units
- Official record key
device-enforcement:Z-0920-2014
Official wording
Reason: Bicarbonate Jug Adapter distributed prior to 510(k) approval
Code information: Unavailable
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Bicarbonate Jug Adapter distributed prior to 510(k) approval