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U.S. Department of Health and Human Services

Class 2 Device Recall Hemocor High Performance Hemoconcentrator

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  Class 2 Device Recall Hemocor High Performance Hemoconcentrator see related information
Date Initiated by Firm August 03, 2015
Date Posted September 11, 2015
Recall Status1 Terminated 3 on November 04, 2015
Recall Number Z-2761-2015
Recall Event ID 72122
510(K)Number K983085  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
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.

Code Information Lot 759491A
Recalling Firm/
Manufacturer		 Medivators, Inc.
14605 28th Ave N
Plymouth MN 55447-4822
For Additional Information Contact Suzanne London
763-553-3348
Manufacturer Reason
for Recall		 Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = MINNTECH CORP.
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