ASSY — Class II medical device recall Z-1015-2015
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2015-02-04, distributed in FL, OK. Unqualified power assemblies shipped to customers.
| Recall number | Z-1015-2015 |
|---|---|
| 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 | 2014-12-16 |
| Classified | 2015-01-27 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2021-01-29 |
| Distributed | FL, OK |
| Quantity | 10 |
Product
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Reason for recall
Unqualified power assemblies shipped to customers.
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-1015-2015. 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.