Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
This recall has been terminated (originally issued March 29, 2013).
- Company
- Zyno Medical Llc
- Recall Initiated
- June 13, 2011
- Posted
- March 29, 2013
- Terminated
- July 25, 2016
- Recall Number
- Z-1024-2013
- Quantity
- 2589 units
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
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
Nationwide Distribution.
Lot / Code Info
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
Root Cause
Process design
Action Taken
Zyno Medical initiated recall 6/13/11 to accounts advising of a Preventative Maintenance (PM) Schedule and a software upgrade Odometer to monitor counts of accumulative fluid volume infused by the unit. On 3/1/13, firm issued correction notice to users that have not had the software implemented on their unit. Units will be serviced at their scheduled PM. The notice identified the product, problem, and actions to be taken by the customers.