BEUDAMED
    FDA Recall Terminated

    Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic

    Recall: Z-0942-03 · Initiated June 2, 2003

    Recall

    Recall Number
    Z-0942-03
    Event Number
    26426
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2003
    Posted
    June 12, 2003
    Terminated
    September 8, 2003
    Address
    1430 Waukegan Rd, McGaw Park, IL, 60085

    Description

    Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic

    Reason

    The product was shipped prior to being sterilized.

    Action

    Recalled by telephone call and follow-up letter on 6/2/03. The accounts were informed that the biopsy needles were not sterile, and were requested to examine their inventory for the affected lot and return any found for credit and replacement.

    Distribution

    Florida, Georgia, Minnesota, Oklahoma, Ohio, Missouri and internationally to Malaysia.

    Quantity

    50 needles