Device product
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Z-0825-2021
Product summary
- Event
- Event 86855
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 592 drums
- Official record key
device-enforcement:Z-0825-2021
Official wording
Reason: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Code information: Lot Numbers: 20LXAC070 20LXAC103 20NXAC021 20LXAC100 20LXAC026 20LXAC027 20LXAC028 20LXAC029 20LXAC065 20LXAC067 20LXAC071 20NXAC001 20NXAC019 20NXAC020 20NXAC029 Additional affected lots as of 3/17/21: 20LXAC103 20LXAC082 20LXAC025 20LXAC081 20LXAC083
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.