FDA Enforcement
Class II
Terminated
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.
Recall: Z-1010-2018
·
Reported March 21, 2018
Enforcement
- Recall Number
- Z-1010-2018
- Event ID
- 79236
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- March 21, 2018
- Initiation Date
- September 29, 2017
- Classification Date
- March 14, 2018
- Termination Date
- August 9, 2018
- Address
- 920 Winter St, Waltham, MA, 02451-1521, United States
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
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 Info
Lot # 17KTAC076; UDI-00840861101696
Distribution
US Distribution to states of: CA, FL, KS, LA, and TX.
Quantity
598 cases