BEUDAMED
    FDA Recall Terminated

    Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Cardinal Health, McGaw Park, IL 60085; catalog #SSI-0003

    Recall: Z-1178-2008 · Initiated February 12, 2008

    Recall

    Recall Number
    Z-1178-2008
    Event Number
    46795
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    LRW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 12, 2008
    Posted
    June 11, 2008
    Terminated
    October 16, 2008
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Cardinal Health, McGaw Park, IL 60085; catalog #SSI-0003

    Reason

    The product has the potential of being non-sterile.

    Action

    Cardinal Health notified the accounts who ordered the affected scissors via letter dated 2/12/08, informing them that the scissors that were labeled sterile were subject to a sterility test failure. Upon review of the letter, the accounts were requested to inspect their inventory and immediately segregate any affected product and to telephone Cardinal Customer Sales Operations Group at 1-800-766-0706 for return instructions and to obtain credit/replacement. Any questions were directed to Cardinal's Quality Systems, Professional Services at 800-292-9332.

    Distribution

    USA Distribution: Kansas and Missouri

    Quantity

    16 cases