Device product
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Z-2686-2014
Product summary
- Event
- Event 69158
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 cases
- Official record key
device-enforcement:Z-2686-2014
Official wording
Reason: Product was held at temperature above the labeled recommended storage temperature
Code information: Lot Number: 14BMLB012
Distribution pattern: Distributed in Texas.
Derived failure modes
-
Unknown
Product was held at temperature above the labeled recommended storage temperature