Z-2761-2015Class II

Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700...

Name: Z-2761-2015 Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700...
Creator: Medivators, Inc.
Published: 2015-08-03
License: https://open.fda.gov/license/

Medivators Inc / initiated 2015-08-03 / Terminated / root cause: manufacturing process

FDA source

Medivators, Inc. began a recall of Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration... on 2015-08-03. FDA classified it as Class II and gives the reason as "Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2761-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-03
Posted: 2015-09-11
Terminated: 2015-11-04
Recalling firm: Medivators Inc
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medivators sent an "Urgent Medical Device" recall letter, dated August 4, 2015, via email. The letter described the issue, identified the affected lot, requested the product be quarantined, and to contact Medivators for return instructions and credit or no-charge replacement product. A response form was requested to be returned to Medivators. Customers with questions can contact Medivators Product at 763-553-3348.
Quantity in commerce: 840 units
Distribution: US Distribution to the states of CA and MI.
Product codes and lots: Lot 759491A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2761-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2761-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-11

Product code KDI

K983085Class IIHemocor Hph 700 HemoconcentratorMinntech Corp. / cleared 1998-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)