Recall Z-1024-2013 ยท OPP Pump, Infusion, Insulin Bolus
Zyno Medical LLC
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
| Date | Mar 29, 2013 (initiated Jun 13, 2011) |
| Status | Terminated |
| Reason | Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump |
| Root cause | Process design |
| Action | 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. |
| Quantity | 2589 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |