| Class 2 Device Recall Polyflux Revaclear, Capillary Dialyzer | |
Date Initiated by Firm | April 16, 2014 |
Date Posted | May 21, 2014 |
Recall Status1 |
Terminated 3 on December 08, 2015 |
Recall Number | Z-1643-2014 |
Recall Event ID |
67996 |
510(K)Number | K072232 |
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
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Product | Polyflux Revaclear, Capillary Dialyzer, Model Number 110633;
Gambro Renal Products, Inc.
Intended for the treatment of acute and chronic renal failure by hemodialysis. |
Code Information |
Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801. |
Recalling Firm/ Manufacturer |
Gambro Renal Products, Incorporated 14143 Denver West Pkwy Lakewood CO 80401-3266
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For Additional Information Contact | Christy (Hummel) Noland 303-232-6800 |
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 | Storage |
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 |
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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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510(K) Database | 510(K)s with Product Code = KDI
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