Hemocor High Performance Hemoconcentrator — Class II medical device recall Z-2761-2015
Terminated recall by Medivators, Inc., reported 2015-09-23, distributed in CA, MI. Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
| Recall number | Z-2761-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medivators, Inc., Plymouth, MN, United States |
| Recall initiated | 2015-08-03 |
| Classified | 2015-09-11 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2015-11-04 |
| Distributed | CA, MI |
| Quantity | 840 units |
| Lot numbers | 759491A |
Product
Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.
Reason for recall
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
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-2761-2015. 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.