BEUDAMED
    FDA Enforcement Class II Terminated

    Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072

    Recall: Z-2058-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2058-2019
    Event ID
    83026
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zyno Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 31, 2019
    Initiation Date
    May 29, 2019
    Classification Date
    July 23, 2019
    Termination Date
    June 22, 2020
    Address
    177 Pine St, N/A, Natick, MA, 01760-1331, United States

    Description

    Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072

    Reason

    Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified

    Code Info

    Lot Numbers:18037128,18065375, 19015969 UDl/UPC/GTIN: 00814371020198

    Distribution

    MA

    Quantity

    354 cases (50/case)=17700