BEUDAMED
    FDA Recall Terminated

    3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

    Recall: Z-0027-2007 · Initiated August 9, 2006

    Recall

    Recall Number
    Z-0027-2007
    Event Number
    36180
    FEI Number
    2110898
    Product Code
    JOJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 9, 2006
    Posted
    October 11, 2006
    Terminated
    May 25, 2007
    Address
    Bldg 275-05-W-06 3M Company Medical Division 3M Center, South St Paul, MN, 55411

    Description

    3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

    Reason

    3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.

    Action

    The firm initiated a recall of the Comply 1248 product made with the discrepant material. Customer letters were sent on August 14, 2006. Letters notified customers of problem and instructed them to discontinue distribution or use of the product. Then to return all affected product to them.

    Distribution

    Nationwide.

    Quantity

    6248 cases (4 boxes/case)