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U.S. Department of Health and Human Services

Class 2 Device Recall Zyno Z800 Volumetric Infusion System

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 Class 2 Device Recall Zyno Z800 Volumetric Infusion System see related information
Date Posted March 29, 2013
Recall Status1 Terminated
Recall Number Z-1024-2013
Recall Event ID 64448
510(K)Number K100705  K071545 
Product Classification Pump, infusion, insulin bolus - Product Code OPP
Product Z-800 Volumetric Infusion System.

For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Code Information 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
Recalling Firm/
Manufacturer
Zyno Medical LLC
10 Tech Circle
Natick MA 01760
For Additional Information Contact
508-650-2008
Manufacturer 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
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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