Z-1024-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2013
- Initiation Date
- June 13, 2011
- Termination Date
- July 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2589 units
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
Distribution Pattern
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