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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

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.
Recall Number Z-1455-2014
Classification Class II
Code Info Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553
Product Distributed Qty 306,525 sets (20435 boxes of 15 sets)
Reason For Recall Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

Event Detail

Event Id 67797
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 2013-12-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
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