Device product
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Z-1859-2021
Product summary
- Firm
- Medivators, Inc.
- Event
- Event 87894
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,381 CASES
- Official record key
device-enforcement:Z-1859-2021
Official wording
Reason: The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Code information: Lot 489224
Distribution pattern: US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
Derived failure modes
-
Potency or specification failure
out of specification