Medivators, Inc. Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Brand
Medivators, Inc.
Lot Codes / Batch Numbers
Lot 489224
Products Sold
Lot 489224
Medivators, Inc. is recalling Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbo due to The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Recommended Action
Per FDA guidance
On 4/20/21 the firm initiated notification to its consignee via phone call, followed by a letter sent on 4/27/21 with the following instructions: 1. Quarantine and discontinue use of product from lot 489224, including dialysate produced with this lot of concentrate. 2. Contact Medivators Customer Service at 1-800-444-4729 or custserv@medivators.com to receive a return material authorization to return any unused product and receive replacement product. 3. Please return the enclosed Acknowledgement form via email to Happy-Sarah Kim at happy-sarah.kim@cantel.com 4. If this product was further distributed, notify your customer of the recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026