BEUDAMED
    FDA Recall Terminated

    STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

    Recall: Z-0745-2014 · Initiated December 16, 2013

    Recall

    Recall Number
    Z-0745-2014
    Event Number
    67043
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    FLF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2013
    Posted
    January 14, 2014
    Terminated
    March 27, 2014
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

    Reason

    Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

    Action

    Advanced Sterilization Products (ASP) sent an Urgent Medical Device Field Safety Notification dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the customer response forms. Customers with questions were also instructed to contact ASP Professional Services directly at (888) 783-7723 and select option number 2. For questions regarding this recall call 949-453-6400.

    Distribution

    Nationwide Distribution

    Quantity

    233 units