BEUDAMED
    FDA Enforcement Class II Terminated

    BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622

    Recall: Z-1721-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1721-2018
    Event ID
    79873
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    October 19, 2017
    Classification Date
    May 8, 2018
    Termination Date
    April 24, 2020
    Address
    15 Law Dr, N/A, Fairfield, NJ, 07004-3206, United States

    Description

    BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622

    Reason

    The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

    Code Info

    Lot 3000058734, 3000063711,

    Distribution

    Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

    Quantity

    9