BEUDAMED
    FDA Recall Terminated

    Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box, and stock code 5000115, packaged in single unit blue cap packaging, 200 per box; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089

    Recall: Z-0905-05 · Initiated May 5, 2005

    Recall

    Recall Number
    Z-0905-05
    Event Number
    31966
    Firm
    Efoora, Inc. dba Virotek, L.L.C.
    FEI Number
    3002689104
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2005
    Posted
    June 17, 2005
    Terminated
    September 2, 2008
    Address
    900 Asbury Dr, Buffalo Grove, IL, 60089-4557

    Description

    Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box, and stock code 5000115, packaged in single unit blue cap packaging, 200 per box; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089

    Reason

    The sterility of the lancets may be compromised due to inadequate packaging seals.

    Action

    Efoora/Virotek sent recall notifications to their customers via fax and DHL delivery on 5/5/05 through 5/27/05. The accounts were informed that the sterility of the lancets had been compromised due to inadequate seals. The accounts were requested to check their inventories for the affected lots, discontinue their use/distribution, and return the product to Efoora for a refund. Any questions were directed to Mary Hill, Director of Quality Assurance at 847-634-4500, ext. 277.

    Distribution

    Nationwide and internationally to Australia, Belgium, Bolivia, Colombia, Finland, Israel, Italy, Japan, Mexico, Nigeria, Russia, Singapore, South Africa, Spain, Sweden, Taiwan, Trinidad, United Kingdom and Zimbabwe.

    Quantity

    763,500 units