Home / Recalls / Gambro Renal Products, Incorporated / Z-1643-2014

Z-1643-2014 Class II Terminated

Recalled by Gambro Renal Products, Incorporated — Lakewood, CO

Recall Details

Product Type
Devices
Report Date
May 28, 2014
Initiation Date
April 16, 2014
Termination Date
December 8, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,461,824 units total

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.

Reason for Recall

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Distribution Pattern

Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.

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.

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