BEUDAMED
    FDA Recall Terminated

    Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Recall: Z-1570-2009 · Initiated January 12, 2009

    Recall

    Recall Number
    Z-1570-2009
    Event Number
    52124
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2009
    Posted
    June 30, 2009
    Terminated
    December 28, 2011
    Address
    33 Technology Drive, Irvine, CA, 92618

    Description

    Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Reason

    The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.

    Action

    Advanced Sterilization Products (ASP) sent an "Urgent: Product Correction" letter dated January 12, 2009 to each consignee informing them of the issue and instructed them to report smoke or a burning odors in or around their STERRAD 50 System. ASP strongly recommended for consignees to follow their facility's safety protocols and if possible, immediately disconnect the STERRAD 50 System from its electrical source. Customers were instructed to contact ASP to schedule an onsite visit to investigate the issue. If the issue is caused by a malfunctioning capacitor in the vacuum pump, the firm will replace the malfunctioning component right away. To correct this situation, an ASP Field Service Engineer (FSE) will visit all customers facilities within the next sixty days to replace the capacitor in the vacuum pump on the affected STERRAD 50 System.

    Distribution

    Worldwide Distribution -- US, Germany, Italy, France, United Kingdom, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Belgium, Puerto Rico, Mexico, Philipines, Australia, Japan, Korea, Malaysia, Taiwan, Middle East, Peru, Canada, Czech Republic, Portugal, Spain, Sweden, Hungary, Poland, Brazil, Russia, Finland, Norway, Panama and Switzerland.

    Quantity

    1,151 units.