Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003...
FDA Recall #Z-1455-2014 — Class II — December 9, 2013
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.
Recalling Firm
Gambro Renal Products, Incorporated — Lakewood, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
306,525 sets (20435 boxes of 15 sets)
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.