Device product
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Z-0821-2021
Product summary
- Event
- Event 86855
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1780 cases
- Official record key
device-enforcement:Z-0821-2021
Official wording
Reason: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information: Lot Numbers: 20LXAC092 20NXAC006 20NXAC027
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.