FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
- Recall number
- Z-1693-2013
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
- Status
- Terminated
- Initiated
- 2013-05-24
- Posted
- 2013-07-11
- Terminated
- 2019-10-07
- Reason
- Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
- Root cause
- Nonconforming Material/Component
- Action
- Fresenius notified customers on May 24, 2013, by telephone and by certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they will be instructed to immediately discontinue use and place all 0-rings in a secure area for return to Fresenius Medical Care North America. Please contact your Fresenius Medical Care Technical Service Team at 1-800-227-2572, (choose option 4, then option 2) for instructions how to return the recalled product.
- Quantity
- 725 units
- Distribution
- Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.
- Lot, serial or model codes
- Part Number: 640919
- 510(k) numbers
- ["K080964","K093902","K101715","K111639","K113427","K120505"]
- 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