BEUDAMED
    FDA Recall Terminated

    Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distributed by Coloplast Corp Minneapolis MN 55411. InterDry" is a non-sterile, knitted, polyurethane-coated polyester textile impregnated with an antimicrobial silver complex used for the management of skin fold complications. The textile provides moisture transportation to keep skin dry while the antimicrobial in the textile reduces odor. The textile's low friction surface acts as a lubrication aid, thereby reducing skin-to-skin friction. InterDry" provides a protective environment for the skin and an effective protection against microbial contamination in the fabric. The product reduces colonization of the following gram-negative and gram-positive bacterial as well as yeast. Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa and Candida albicans. InterDry" Ag Textile contains 0.01% silver and is a single patient use product that is custom cut from a multi-use package.

    Recall: Z-1996-2009 · Initiated July 21, 2009

    Recall

    Recall Number
    Z-1996-2009
    Event Number
    52801
    Firm
    Coloplast Corp Skin Care Div
    FEI Number
    2125337
    Product Code
    FRL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 21, 2009
    Posted
    September 4, 2009
    Terminated
    January 11, 2011
    Address
    1940 Commerce Dr, North Mankato, MN, 56003-1700

    Description

    Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distributed by Coloplast Corp Minneapolis MN 55411. InterDry" is a non-sterile, knitted, polyurethane-coated polyester textile impregnated with an antimicrobial silver complex used for the management of skin fold complications. The textile provides moisture transportation to keep skin dry while the antimicrobial in the textile reduces odor. The textile's low friction surface acts as a lubrication aid, thereby reducing skin-to-skin friction. InterDry" provides a protective environment for the skin and an effective protection against microbial contamination in the fabric. The product reduces colonization of the following gram-negative and gram-positive bacterial as well as yeast. Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa and Candida albicans. InterDry" Ag Textile contains 0.01% silver and is a single patient use product that is custom cut from a multi-use package.

    Reason

    Coloplast determined that a portion of one lot of InterDry" Ag Lot number 1789435, did not meet the product specification for silver content. In this portion of the lot antimicrobial properties of the product could be compromised although the absorption and transportation of moisture would be as expected.

    Action

    Consignees were faxed on 7/27/09 a Coloplast "Product Recall" letter dated July 2009. The letter addressed the problem and requested consignees to contact Coloplast Customer Service at 1-800-533-0464 to communicate the status of the product. Replacement product will be provided upon receipt of returned product. It also advised distributors to contact their customers immediately and advise them of the recall and to return the product them. Questions or concerns should be directed to the customer's customer care rep at 1-800-533-0464.

    Distribution

    Worldwide Distribution -- USA, including states of AL, AZ, CA, CT, FL, GA, IL, IN, IA, KY. LA, MI, MA,MO, MN, MS, MD, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and country of CANADA.

    Quantity

    USA, 876 cases (10 rolls/case) ; Canada 53.9 cases (10 rolls/case)