BEUDAMED
    FDA Recall 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 · Initiated January 28, 2016

    Recall

    Recall Number
    Z-1047-2016
    Event Number
    73151
    Firm
    Gi Supply
    FEI Number
    1000121355
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 28, 2016
    Terminated
    December 7, 2016
    Address
    200 Grandview Ave, Camp Hill, PA, 17011-1706

    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.

    Action

    The customers will be made aware of the defect, including pictures provided and are instructed to inspect the RP Bags in the kit prior to use. If the pinch clamp is missing, the customer is instructed to discard the RP Bag and use the sterile RP Bag replacements provided.

    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