BEUDAMED
    FDA Enforcement Class II Terminated

    Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-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-2895-2016 · Reported October 5, 2016

    Enforcement

    Recall Number
    Z-2895-2016
    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: B2-70071-DF Product Code: B2-70071-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

    B2-70071-DF Lot Codes: 14015279 14026620 14046841 14055191 14055786 14056225 14085743 14085742 15035297 15045941 15045940 15046600 15075275 15075835 15076761 15085107 15086621 15095200 15095647 15097179 15105595 B2-70071-DF-120 lot codes: 15066912 15075253 15075990 15076261 15076304

    Distribution

    US Nationwide Distribution

    Quantity

    78063 sets