BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650, Order No M00516501.

    Recall: Z-0377-06 · Initiated December 8, 2005

    Recall

    Recall Number
    Z-0377-06
    Event Number
    34241
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    BTG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 8, 2005
    Posted
    January 11, 2006
    Terminated
    March 16, 2007
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650, Order No M00516501.

    Reason

    The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.

    Action

    Consignees were notified via letter dated December 8, 2005.

    Distribution

    Nationwide, Aruba, Australia, Belize, Bolivia, Bulgaria, Chile, China, Dominican Republic, Ecuador, Guatemala, Haiti, Honduras, Hong Kong, India, Indonesia, Israel, Jamaica, Jordan, Korea, Kuwait, Lebanon, Malaysia, Moldavia, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad, Tobago, and Venezuela.

    Quantity

    12350