Device product
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.
Z-2110-2018
Product summary
- Event
- Event 80101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1060 cases (4240 bottles)
- Official record key
device-enforcement:Z-2110-2018
Official wording
Reason: The bottles are mislabeled with an incorrect part number.
Code information: Lot Code: 18CXAC095
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.
Derived failure modes
-
Labeling or packaging
mislabeled