BEUDAMED
    FDA Enforcement Class II Terminated

    PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

    Recall: Z-2049-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2049-2016
    Event ID
    74226
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    May 23, 2016
    Classification Date
    June 24, 2016
    Termination Date
    March 28, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

    Reason

    Presence of leaks near top of the PrismaSate bags

    Code Info

    Listing #D051124, Unique Device Identifier #07332414037048, Product code #105351. Lot code (Exp date): 1000123133 (02/28/2017), 1000128162 (04/30/2017), 1000128163 (04/30/2017), 1000128164 (04/30/2017).

    Distribution

    Distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI

    Quantity

    10,054 units