BEUDAMED
    FDA Recall Terminated

    Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251.

    Recall: Z-1300-06 · Initiated June 30, 2006

    Recall

    Recall Number
    Z-1300-06
    Event Number
    35748
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    KOG
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    June 30, 2006
    Posted
    July 27, 2006
    Terminated
    July 31, 2008
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251.

    Reason

    Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.

    Action

    U.S. accounts were notified via recall letter dated 6/30/06 to cease use of the product and to return it to the firm. International accounts were also notified.

    Distribution

    Nationwide and worldwide, including Argentina, Bangladesh, Belgium, Canada, Chile, China, Colombia, Dominican Republic, Egypt, El Salvador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Portugal, Romania, South Africa, Spain, Sri Lanka, Sweden, Tunisia, Turkey and Venezuela.

    Quantity

    446,097 units