Home / Recalls / Gambro Renal Products, Incorporated / Z-1455-2014

Z-1455-2014 Class II Terminated

Recalled by Gambro Renal Products, Incorporated — Lakewood, CO

Recall Details

Product Type
Devices
Report Date
April 23, 2014
Initiation Date
December 9, 2013
Termination Date
December 22, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
306,525 sets (20435 boxes of 15 sets)

Product Description

Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

Reason for Recall

Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.

Code Information

Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553

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