BEUDAMED
    FDA Enforcement Class II Terminated

    13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

    Recall: Z-0425-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0425-2014
    Event ID
    65356
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    April 4, 2013
    Classification Date
    November 27, 2013
    Termination Date
    August 26, 2014
    Address
    901 Marcon Boulevard, N/A, Allentown, PA, 18109-9512, United States

    Description

    13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

    Reason

    Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result i

    Code Info

    Material BC1300, Lot number 61286479.

    Distribution

    Nationwide Distribution

    Quantity

    4,000 units