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.
FDA Recall Z-2761-2015 · Posted 2015-09-11
Advertisement
Recalling FirmMedivators, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2015-08-03
Date Terminated2015-11-04
Product Quantity840 units
Reason for Recall
Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Distribution to the states of CA and MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement