BEUDAMED
    FDA Enforcement Class II Terminated

    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.

    Recall: Z-1680-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1680-2014
    Event ID
    68305
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bacterin International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 11, 2014
    Initiation Date
    May 15, 2014
    Classification Date
    June 2, 2014
    Termination Date
    June 2, 2014
    Address
    600 Cruiser Ln, Belgrade, MT, 59714-9719, United States

    Description

    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.

    Reason

    The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized

    Code Info

    19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..

    Distribution

    Distributed to one foreign consignee in Lebanon.

    Quantity

    390