Fresenius Service Replacement 0-Ring — Class II medical device recall Z-1693-2013
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2013-07-17, distributed nationwide. Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Mo
| Recall number | Z-1693-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2013-05-24 |
| Classified | 2013-07-11 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2019-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 725 units |
| Model numbers | 2008K, 2008K2, 2008T, 640919 |
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
Reason for recall
Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1693-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.