FDA Device recall Z-2761-2015
Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use a…
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use a… by Medivators, citing hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2761-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-03 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medivators |
| Distribution | CA, MI |
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
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Identifiers
| code_info | Lot 759491A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2761-2015%22
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