BEUDAMED
    FDA Recall Terminated

    Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisting of a bag connector (spike connector), on-off clamp assembly, tubing and double sealing male Luer lock connector; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code R5C4325

    Recall: Z-0301-05 · Initiated November 5, 2004

    Recall

    Recall Number
    Z-0301-05
    Event Number
    30495
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KDJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 5, 2004
    Posted
    December 9, 2004
    Terminated
    May 16, 2006
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisting of a bag connector (spike connector), on-off clamp assembly, tubing and double sealing male Luer lock connector; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code R5C4325

    Reason

    Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.

    Action

    Recall by letter dated 11/05/04. The customers were instructed to stop using this lot of product, return any stocks of the lot back to Baxter, and that replacement of the patient''s set be completed at the dialysis center.

    Distribution

    The entire lot was distributed overseas to Belgium, Sweden, Norway, the United Kingdom, Germany and France.

    Quantity

    1,152 sets