FDAFDA · Food and drugs·Recall number Z-1455-2014
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.
Published April 23, 2014 · Recall initiated: December 9, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gambro Renal Products, Incorporated
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
- Lot
- Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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