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Terminated

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

FDA Recall Z-1024-2013 · Posted 2013-03-29

Recalling FirmZyno Medical LLC
Recall StatusTerminated
Product CodeOPP
Date Initiated2011-06-13
Date Terminated2016-07-25
Product Quantity2589 units

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

Firm 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.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100705ZYNO Z-800 INFUSION SYSTEM MODEL Z-800Zyno Medical, LLC · 2010-07-08K071545Z-800 VOLUMETRIC INFUSION PUMPZyno Medical, LLC · 2007-10-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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