BEUDAMED
    FDA Recall Terminated

    Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation, Deerfield, IL 60015

    Recall: Z-0521-03 · Initiated October 17, 2002

    Recall

    Recall Number
    Z-0521-03
    Event Number
    25088
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 17, 2002
    Posted
    February 6, 2003
    Terminated
    February 4, 2004
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation, Deerfield, IL 60015

    Reason

    The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

    Action

    Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.

    Distribution

    Nationwide, Australia, Puerto Rico, Brazil, Canada, Sweden, New Zealand, Japan, Mexico, American Samoa, El Salvador, Turkey, Saudi Arabia, Austria, Cayman Islands, Macedonia, Honduras, Kuwait, Hong Kong and Nigeria.

    Quantity

    630,140 units