Recall Z-2761-2015— Medivators, Inc.
Class II · Terminated
Class II FDA medical device recall by Medivators, Inc., initiated 2015-08-03, terminated 2015-11-04. It names one FDA 510(k) clearance: K983085. 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..
- Recalling firm
- Medivators, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-03
- Terminated
- 2015-11-04
- Firm location
- Plymouth, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.