BEUDAMED
    FDA Enforcement Class II Terminated

    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.

    Recall: Z-2894-2016 · Reported October 5, 2016

    Enforcement

    Recall Number
    Z-2894-2016
    Event ID
    74892
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zyno Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2016
    Initiation Date
    July 29, 2016
    Classification Date
    September 27, 2016
    Termination Date
    July 11, 2017
    Address
    10 Tech Cir, N/A, Natick, MA, 01760-1029, United States

    Description

    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.

    Reason

    Administration Set potential filter leaking

    Code Info

    Lot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499

    Distribution

    US Nationwide Distribution

    Quantity

    78069 sets