BEUDAMED
    FDA Recall Terminated

    3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ

    Recall: Z-0838-03 · Initiated April 7, 2003

    Recall

    Recall Number
    Z-0838-03
    Event Number
    25979
    FEI Number
    2110898
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 7, 2003
    Posted
    May 16, 2003
    Terminated
    July 2, 2004
    Address
    3m Health Care 3m Center, Saint Paul, MN, 55144-1001

    Description

    3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ

    Reason

    The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.

    Action

    3M sent Cardinal Health a letter dated April 7, 2003 to provide to their customers. The letter instructed the customers to remove Ioban 2 drapes contained in Cardinal Health packs and use a separately supplied equivalent drape.

    Distribution

    Procedure packs containing the drapes were shipped nationwide in United States.

    Quantity

    3679 drapes