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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 Initiated by Firm June 13, 2011
Date Posted March 29, 2013
Recall Status1 Terminated 3 on July 25, 2016
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 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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