BEUDAMED
    FDA Recall Terminated

    STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customers, Product Code 15-53231; STERRAD NX System Brochure, Product Code AD-53421-001, Advanced Sterilization Products, Irvine, CA

    Recall: Z-0844-2008 · Initiated November 12, 2007

    Recall

    Recall Number
    Z-0844-2008
    Event Number
    45846
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 12, 2007
    Posted
    February 7, 2008
    Terminated
    December 19, 2011
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customers, Product Code 15-53231; STERRAD NX System Brochure, Product Code AD-53421-001, Advanced Sterilization Products, Irvine, CA

    Reason

    Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities

    Action

    Notification letters, Urgent Product Correction, were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken as a result of an investigation by the firm determined that all brand- and model-specific compatibility lists and associated instrument assessments provided to STERRAD Sterilization System customers are now out-of-date. User were instructed to discontinue their use and destroy them.

    Distribution

    Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux,Uruguay,Venezuela,Argentina,Chile,Colombia,Ecuador,Belgium, Puerto Rico, Hong Kong,Indonesia,Mexico,Philippines,Australia,Austria,China, Greece,Ireland,Israel, Japan,Korea,Malaysia,Singapore,Taiwan,Thailand, Turkey, Middle East, Peru,Canada,The Czech Republic,Portugal,S Africa, Spain,Sweden,Hungary,Poland,Brazil,Russia,Egypt,India &Slovenia and Canada

    Quantity

    9,686 units