Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hemocor High Performance Hemoconcentrator Recalled by Medivators, Inc. Due to Hemoconcentrators may exhibit low ultrafiltration performance that is...

Date: August 3, 2015
Company: Medivators, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medivators, Inc. directly.

Affected Products

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.

Quantity: 840 units

Why Was This Recalled?

Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.

Where Was This Sold?

This product was distributed to 2 states: CA, MI

Affected (2 states)Not affected

About Medivators, Inc.

Medivators, Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report