Recall Z-1859-2021— Medivators, Inc.
Class II · Terminated
Class II FDA medical device recall by Medivators, Inc., initiated 2021-04-20, terminated 2024-07-11. It names one FDA 510(k) clearance: K843963. Product: Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.. Reason: The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation..
- Recalling firm
- Medivators, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-20
- Terminated
- 2024-07-11
- Firm location
- Plymouth, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Reason for recall
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.