Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Reported: June 23, 2021 Initiated: April 20, 2021 #Z-1859-2021
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.
Details
- Recalling Firm
- Medivators, Inc.
- Units Affected
- 1,381 CASES
- Distribution
- US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.. Recalled by Medivators, Inc.. Units affected: 1,381 CASES.
Why was this product recalled? ▼
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1859-2021.
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