Device product
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Z-1010-2018
Product summary
- Event
- Event 79236
- Status
- Terminated
- Classification
- Class II
- Quantity
- 598 cases
- Official record key
device-enforcement:Z-1010-2018
Official wording
Reason: The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
Code information: Lot # 17KTAC076; UDI-00840861101696
Distribution pattern: US Distribution to states of: CA, FL, KS, LA, and TX.
Derived failure modes
-
Unknown
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.