FDA Medical Device Recalls (openFDA)
Medivators, Inc.: Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
- Recall number
- Z-1859-2021
- Recalling firm
- Medivators, Inc.
- Product
- Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
- Status
- Terminated
- Initiated
- 2021-04-20
- Posted
- not on file
- Terminated
- 2024-07-11
- Reason
- The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 1,381 CASES
- Distribution
- US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
- Lot, serial or model codes
- Lot 489224
- 510(k) numbers
- K843963
- PMA numbers
- not on file
- Product code
- FKQ
- Firm FEI
- 2150060
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28