BEUDAMED
    FDA Recall Terminated

    ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.

    Recall: Z-0306-2012 · Initiated June 30, 2008

    Recall

    Recall Number
    Z-0306-2012
    Event Number
    60192
    Firm
    Acrymed Incorporated
    FEI Number
    3006646024
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 30, 2008
    Posted
    November 29, 2011
    Terminated
    December 20, 2011
    Address
    9650 SW Nimbus Ave, Beaverton, OR, 97008-7171

    Description

    ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.

    Reason

    The Silver Dressing, lot H0705J and H0706J may contain dressings that are not properly sealed in the foil pouch, which could affect sterility of the dressing.

    Action

    On June 30 2008, the firm e-mailed all affected customers with an Important Product Recall Notification letter. The customers were notified that two lots of SilverDressing may contain dressings that are not properly seated in the foil pouch. The customers were instructed to inspect the inventory, ceased distribution of the affected lots and quaratine the remaining inventory and notify AcryMed. Customers can call AcryMed at 503-624-9830 for any questions about this recall.

    Distribution

    Nationwide distribution -- DE, FL, KY, OR, IN, TX, NV, MT, CA and NY.

    Quantity

    14,125 units from lot # H0706J and 25,525 units from lot # H0705J