BEUDAMED
    FDA Recall Terminated

    Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.

    Recall: Z-1393-2011 · Initiated June 23, 2010

    Recall

    Recall Number
    Z-1393-2011
    Event Number
    56367
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    KCT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 23, 2010
    Posted
    February 22, 2011
    Terminated
    March 14, 2012
    Address
    33 Technology Drive, Irvine, CA, 92618

    Description

    Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.

    Reason

    The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.

    Action

    Advanced Sterilization Products (ASP) released Urgent: Product Recall notifications to its consignees identifying the affected product and explaining the reason for recall. The letter also discussed the impact of using this affected product and return instructions. The firm asked customers to examine their inventory, discontinue use of Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332 and to return all unused affected products to Stericycle. Customers are to complete the Business Reply Card and return it to Stericycle.

    Distribution

    Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico.

    Quantity

    470