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U.S. Department of Health and Human Services

Class 2 Device Recall Polyflux Revaclear

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  Class 2 Device Recall Polyflux Revaclear see related information
Date Initiated by Firm November 05, 2014
Date Posted December 01, 2014
Recall Status1 Terminated 3 on May 20, 2015
Recall Number Z-0490-2015
Recall Event ID 69786
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Polyflux Revaclear Max Dialyzer, Model Number 110634.

The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Code Information Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001
Recalling Firm/
Manufacturer		 Gambro Renal Products Inc
1101 Jeter Ave
Opelika AL 36801-3885
For Additional Information Contact Thomas W. Dielmann
303-390-9120
Manufacturer Reason
for Recall		 Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
FDA Determined
Cause 2		 Process control
Action Recall letter was sent via UPS delivery next day to US customers on November 5th, 2014. Product that is returned will be quarantined at the distribution centers.
Quantity in Commerce 20 million dialyzers
Distribution Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
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.
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