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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 Recall
Zyno Z800 Volumetric Infusion System
see related information
Date Posted March 29, 2013
Recall Status1 Open
Recall Number Z-1024-2013
Recall Event ID 64448
Premarket Notification
510(K) Numbers
K071545  K100705 
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, Massachusetts 01760
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
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
510(K) Database 510(K)s with Product Code = OPP and Original Applicant = ZYNO MEDICAL LLC
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