BEUDAMED
    FDA Enforcement Class II Terminated

    Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04

    Recall: Z-1047-2016 · Reported March 16, 2016

    Enforcement

    Recall Number
    Z-1047-2016
    Event ID
    73151
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gi Supply
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2016
    Initiation Date
    January 28, 2016
    Classification Date
    March 4, 2016
    Termination Date
    December 7, 2016
    Address
    200 Grandview Ave, N/A, Camp Hill, PA, 17011-1706, United States

    Description

    Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04

    Reason

    Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.

    Code Info

    Lot #: 61442434 Expiration Date: 2018/04

    Distribution

    Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.

    Quantity

    390 Kits