BEUDAMED
    FDA Recall Terminated

    Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.

    Recall: Z-2375-2015 · Initiated July 17, 2015

    Recall

    Recall Number
    Z-2375-2015
    Event Number
    71642
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 17, 2015
    Posted
    August 13, 2015
    Terminated
    May 20, 2016
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.

    Reason

    Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators."

    Action

    A Urgent recall letter will be sent to customers to inform them that Advanced Sterilization Products (ASP) is recalling the Wall Chart of the STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete a business reply card for their acknowledgement of the customer letter and documentation of the removal and replacement of the wall chart. Customers are instructed to complete and return the attached Business Reply Card via mail or fax to Stericycle: 877-497-3125. Customers with questions are instructed to contact SteriCycle at 866-737-5389 and reference event #6677.

    Distribution

    Nationwide Distribution.

    Quantity

    1465 units