Z-1010-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- September 29, 2017
- Termination Date
- August 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 598 cases
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution to states of: CA, FL, KS, LA, and TX.
Code Information
Lot # 17KTAC076; UDI-00840861101696