BEUDAMED
    FDA Enforcement Class II Terminated

    Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE

    Recall: Z-0023-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0023-2015
    Event ID
    69249
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomedix, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 15, 2014
    Initiation Date
    August 14, 2014
    Classification Date
    October 6, 2014
    Termination Date
    November 13, 2014
    Address
    3895 W Vernal Pike, Bloomington, IN, 47404-2533, United States

    Description

    Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE

    Reason

    Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.

    Code Info

    Model/Product Number: B30-102 Lot #416130 Exp. 12/2016

    Distribution

    US Distribution including the states of OH, NC, and TX

    Quantity

    2,928