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U.S. Department of Health and Human Services

Class 2 Device Recall Polyflux Revaclear Max, Capillary Dialyzer

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  Class 2 Device Recall Polyflux Revaclear Max, Capillary Dialyzer see related information
Date Initiated by Firm April 16, 2014
Date Posting Updated May 21, 2014
Recall Status1 Terminated 3 on December 08, 2015
Recall Number Z-1644-2014
Recall Event ID 67996
510(K)Number K060195  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634;
Gambro Renal Products, Inc.
Intended for the treatment of acute and chronic renal failure by hemodialysis.
Code Information Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.
Recalling Firm/
Gambro Renal Products, Incorporated
14143 Denver West Pkwy
Lakewood CO 80401-3266
For Additional Information Contact Christy (Hummel) Noland
Manufacturer Reason
for Recall
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
FDA Determined
Cause 2
Action The recall was initiated by an Urgent: Medical Device Recall letter delivered by UPS Overnight Delivery on April 16, 2014. The letter identified the affected product and reason for the recall. The firm is asking customers to remove and quarantine any remaining affected product from their inventory for collection and replacement. Customers are to also complete and return the Customer Reply Form to the Gambro Regulatory Affairs Department. Customers with affected product are to contact Gambro Customer Support or their Gambro representative to return the product. Questions should be directed to Customer Support at 1-800-651-2623.
Quantity in Commerce 2,461,824 units total
Distribution Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
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 = GAMBRO RENAL PRODUCTS