Z-1859-2021 Class II Terminated
FDA device recall Z-1859-2021 was initiated by Medivators, Inc. on April 20, 2021 and is designated Class II. Reason for recall: The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. The recall status is terminated (terminated July 11, 2024). Affected quantity: 1,381 CASES.
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- April 20, 2021
- Termination Date
- July 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,381 CASES
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.
Distribution Pattern
US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
Code Information
Lot 489224