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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Recall Number Z-1643-2014
Classification Class II
Code Info 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.
Product Distributed Qty 2,461,824 units total
Reason For Recall The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Event Detail

Event Id 67996
Product Type Devices
Status Ongoing
Recalling Firm Gambro Renal Products, Incorporated
City Lakewood
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.