BEUDAMED
    FDA Recall Terminated

    Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.

    Recall: Z-0673-06 · Initiated January 23, 2006

    Recall

    Recall Number
    Z-0673-06
    Event Number
    34461
    Firm
    International Technidyne Corp
    FEI Number
    2250033
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 23, 2006
    Posted
    March 23, 2006
    Terminated
    June 30, 2006
    Address
    23 Nevsky St, Edison, NJ, 08820-2425

    Description

    Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.

    Reason

    Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. This is a sterile product.

    Action

    Recall letter was sent out 1/25/2006 via UPS tracking system per the distribution record addressees. With Cardinal Health, the letter was sent out to the firm''s corporate headquarters location.

    Distribution

    Product was distributed nationwide to medical supply distributors. The product was also shipped internationally to 3 countries: Canada, Czech Republic, and New Zealand. There are no Govt. accounts.

    Quantity

    1616 BOXES of 100 pouches