FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Renal Therapies Group, LLC: Fresenius 2008K2 Series : Hemodialysis System
- Recall number
- Z-1028-2017
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- Fresenius 2008K2 Series : Hemodialysis System
- Status
- Terminated
- Initiated
- 2016-12-21
- Posted
- not on file
- Terminated
- 2023-03-17
- Reason
- When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
- Root cause
- Device Design
- Action
- Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM. Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.
- Quantity
- 60,151 units (US) 1773 (OUS)
- Distribution
- Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K150708"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- 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