Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fres
FDA device recall Z-1693-2013 · posted 2013-07-11 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 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.
- Date initiated
- 2013-05-24
- Date posted
- 2013-07-11
- Date terminated
- 2019-10-07
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K120505) | Fresenius Medical Care North America, Design Cente | 2012-03-06 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K113427) | Fresenius Medical Care North America | 2011-12-21 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K111639) | Fresenius Medical Care | 2011-10-21 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 (K101715) | Fresenius Medical Care North America, Design Cente | 2010-12-21 |
| MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 (K093902) | Fresenius Medical Care North America | 2010-05-27 |
| FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE (K080964) | Fresenius Medical Care North America | 2009-01-14 |