Food, drugs, devices › Medivators, Inc.
Device recall: Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is
FDA enforcement event 72122 is a device recall by Medivators, Inc. of Plymouth, MN, initiated 3 Aug 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 4 Nov 2015. Initiation: voluntary: firm initiated. Medivators, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medivators, Inc., Plymouth, MN.
Reason for recall
"Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification."
Distribution
"US Distribution to the states of CA and MI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2761-2015 | 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. | 840 units | Class II | Terminated | 23 Sep 2015 |
Context
Other enforcement events for Medivators, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Apr 2021 | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible | Device | Class II | 1 |
| 9 Oct 2019 | Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for | Device | Class II | 7 |
All 3 events for Medivators, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the states of CA and MI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Nov 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.