FDA Enforcement
Class II
Ongoing
Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Recall: Z-0831-2021
·
Reported January 20, 2021
Enforcement
- Recall Number
- Z-0831-2021
- Event ID
- 86939
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 20, 2021
- Initiation Date
- November 23, 2020
- Classification Date
- January 11, 2021
- Address
- 920 Winter St Bld 950, N/A, Waltham, MA, 02451-1521, United States
Description
Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Reason
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Code Info
Lot Numbers: 20LXAC063 20NXAC008 Additional Affected lots as of 3/17/21: 20NXAC005 20LXAC098 20NXAC039 20NXAC008 20LXAC063
Distribution
US Nationwide distribution.
Quantity
1686 cases