BEUDAMED
    FDA Recall 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 · Initiated May 15, 2014

    Recall

    Recall Number
    Z-1680-2014
    Event Number
    68305
    Firm
    Bacterin International, Inc.
    FEI Number
    3005031160
    Product Code
    OEI
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    May 15, 2014
    Posted
    June 2, 2014
    Terminated
    June 2, 2014
    Address
    600 Cruiser Ln, Belgrade, MT, 59714-9719

    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

    Action

    Bacterin sent e-mail and FedEx letter with return receipt request to it's single consignee on May 15, 2014. Consignee is asked to separate the recalled product in a secure location for return to Bacterin International, Inc. Consignee is asked to complete tracking/verification form included in the letter/e-mail and call 1-888-886-9354 from 8:00AM to 5:00PM (Mountain Time) or send an e-mail to [email protected] to obtain a Return Authorization (RA) number.

    Distribution

    Distributed to one foreign consignee in Lebanon.

    Quantity

    390