Z-2110-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- May 2, 2018
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1060 cases (4240 bottles)
Product Description
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: 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. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
Reason for Recall
The bottles are mislabeled with an incorrect part number.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.
Code Information
Lot Code: 18CXAC095