RecallRadar

FDA Device recall Z-1024-2013

Z-800 Volumetric Infusion System

On 2013-04-10 the FDA classified a Class II recall of Z-800 Volumetric Infusion System by Zyno Medical, citing update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1024-2013
ClassificationClass II
Statusterminated
Initiated2011-06-13
Published2013-04-10
Last updated2026-09-13 11:53 UTC
CompanyZyno Medical
DistributionUS

Product

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

Reason

Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

Identifiers

code_info
LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5,…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 history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1024-2013%22

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