Z-1024-2013Class II

Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to...

Name: Z-1024-2013 Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to...
Creator: Zyno Medical LLC
Published: 2011-06-13
License: https://open.fda.gov/license/

Zyno Medical LLC. / initiated 2011-06-13 / Terminated / root cause: manufacturing process

FDA source

Zyno Medical LLC began a recall of Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient on 2011-06-13. FDA classified it as Class II and gives the reason as "Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1024-2013
Classification: Class II
Status: Terminated
Initiated: 2011-06-13
Posted: 2013-03-29
Terminated: 2016-07-25
Recalling firm: Zyno Medical LLC.
Product: Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Product code: OPP Pump, Infusion, Insulin Bolus
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
Root cause tag: manufacturing process
FDA 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 in commerce: 2589 units
Distribution: Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1024-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1024-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-03-29

Product code OPP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)