Date Initiated by Firm | November 05, 2014 |
Date Posted | December 01, 2014 |
Recall Status1 |
Terminated 3 on May 20, 2015 |
Recall Number | Z-0489-2015 |
Recall Event ID |
69786 |
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
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Product | Polyflux Revaclear Dialyzer, Model Number 110633.
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. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001 |
Recalling Firm/ Manufacturer |
Gambro Renal Products Inc 1101 Jeter Ave Opelika AL 36801-3885
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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 |
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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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