BEUDAMED
    FDA Enforcement Class II Terminated

    Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.

    Recall: Z-0936-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0936-2013
    Event ID
    64326
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bacterin International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 20, 2013
    Initiation Date
    January 28, 2013
    Classification Date
    March 11, 2013
    Termination Date
    July 8, 2013
    Address
    600 Cruiser Ln, N/A, Belgrade, MT, 59714-9719, United States

    Description

    Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.

    Reason

    A portion of a silicone wound drain was found to be cracked.

    Code Info

    005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211

    Distribution

    13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee

    Quantity

    15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee