BEUDAMED
    FDA Enforcement Class II Terminated

    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) 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-2893-2016 · Reported October 5, 2016

    Enforcement

    Recall Number
    Z-2893-2016
    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: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) 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

    Product Code: A2-80071-DF Lot Code: 13125968 13126110 13126111 14026150 14055090 14056598 14065315 14065624 14067149 14075494 14085636 14105960 14106106 14106544 14116251 15045374 15045866 15046986 15055122 15055728 15067196 15085624 15085570 15086315 15086421 15086583 15105241 Product Code:A2-80071-DF-120 Lot code: 15085208

    Distribution

    US Nationwide Distribution

    Quantity

    114081 sets