Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blo...
FDA Recall #Z-1024-2013 — Class II — June 13, 2011
Product Description
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Reason for Recall
Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
Recalling Firm
Zyno Medical LLC — Natick, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2589 units
Distribution
Nationwide Distribution.
Code Information
LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated