BEUDAMED
    FDA Recall Terminated

    SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.

    Recall: Z-1029-2010 · Initiated January 6, 2010

    Recall

    Recall Number
    Z-1029-2010
    Event Number
    54187
    Firm
    Wescor, Inc
    FEI Number
    1717966
    Product Code
    HYB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 6, 2010
    Posted
    March 9, 2010
    Terminated
    April 20, 2010
    Address
    1700 S 370 W, Logan, UT, 84321

    Description

    SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.

    Reason

    Stains used for diagnostic use may be contaminated with bacteria.

    Action

    Customers were notified by letter on Jan. 6, 2010 and asked to destroy any remaining product. A response form was included to note whether or not customer had any remaining stock for replacement purposes. Additional information is available at 800-453-2725 or [email protected].

    Distribution

    Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.

    Quantity

    116 bottles