Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
FDA Recall Z-1643-2014 · Posted 2014-05-21
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Recalling FirmGambro Renal Products, Incorporated
Recall StatusTerminated
Product CodeKDI
Date Initiated2014-04-16
Date Terminated2015-12-08
Product Quantity2,461,824 units total
Reason for Recall
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Firm 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.
Root Cause
Storage
Distribution Pattern
Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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