BEUDAMED
    FDA Recall Terminated

    Fenwal Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 55'', 170 to 260 Micron Filter, catalog 4C2100; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    Recall: Z-1173-03 · Initiated July 16, 2003

    Recall

    Recall Number
    Z-1173-03
    Event Number
    26772
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    KSB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 16, 2003
    Posted
    August 21, 2003
    Terminated
    June 29, 2004
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Fenwal Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 55'', 170 to 260 Micron Filter, catalog 4C2100; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    Reason

    There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

    Action

    Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.

    Distribution

    Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan

    Quantity

    133,008 units