BEUDAMED
    FDA Recall 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 · Initiated January 28, 2013

    Recall

    Recall Number
    Z-0936-2013
    Event Number
    64326
    Firm
    Bacterin International, Inc.
    FEI Number
    3005031160
    Product Code
    OEI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 28, 2013
    Posted
    March 11, 2013
    Terminated
    July 8, 2013
    Address
    600 Cruiser Ln, Belgrade, MT, 59714-9719

    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.

    Action

    Consignees were informed of the recall via e-mail beginning 1/28/13 with a request for a return response. This was followed by a "Voluntary Product Recall Information" letter dated 2/13/13 that described the product issue and provided recommended actions. The firm asked for all product to be returned to them.

    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