BEUDAMED
    FDA Recall Terminated

    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities

    Recall: Z-1251-2016 · Initiated February 24, 2016

    Recall

    Recall Number
    Z-1251-2016
    Event Number
    73324
    Firm
    Amd Ritmed 1200 Av 55e Lachine Canada
    FEI Number
    3002861073
    Product Code
    MHW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 24, 2016
    Terminated
    July 8, 2016

    Description

    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities

    Reason

    Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.

    Action

    AMD Ritmed sent an Urgent - Medical Device Recall letter dated February 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine all stocks immediately to determine if any of the affected product is on hand. If so, please discontinue distributing the product immediately and promptly return. If customers further distributed any of the product, please immediately contact your accounts advise them of the recall situation, and have them return their outstanding recalled stocks to you. Return these stocks as indicated above. Please return the enclosed response form immediately providing the requested information by fax 1-866-871-3455 or by email: [email protected]. Customers with questions can call 1-800-445-0340 or email AMD Customer Service: [email protected].

    Distribution

    US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.

    Quantity

    126 cases total (87 cases domestically and 39 cases internationally)