BEUDAMED
    FDA Recall Terminated

    STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CA

    Recall: Z-0846-2008 · Initiated November 12, 2007

    Recall

    Recall Number
    Z-0846-2008
    Event Number
    45851
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 12, 2007
    Posted
    February 8, 2008
    Terminated
    March 14, 2012
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CA

    Reason

    User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.

    Action

    Urgent Product Correction letters were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken to clarify instructions contained within the STERRAD System User Guides to reinforce appropriate use and to address two separate issues which have arisen from user reports: (1) User reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization. (2) User reports about light-colored residues observed on instruments, trays and pouches after sterilization. The Product Correction Letters instructed customers to refer to the revised excerpt of the User Guide (attached to the letter) for information about instrument preparation prior to sterilization, particularly with regard to the washing, rinsing and thorough drying of instruments prior to sterilization in the STERRAD Sterilization System. If customers have any questions they were instructed to call ASP Customer Care Center to answer additional questions at (888) 783-7723.

    Distribution

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

    Quantity

    9,686 units total for recalls Z-0845-0848-2008