BEUDAMED
    FDA Recall Terminated

    Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only).

    Recall: Z-1117-06 · Initiated March 31, 2006

    Recall

    Recall Number
    Z-1117-06
    Event Number
    34905
    Firm
    Disetronic Medical Systems, Inc.
    FEI Number
    1000116163
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 31, 2006
    Posted
    July 8, 2006
    Terminated
    November 6, 2007
    Address
    11800 Exit 5 Parkway, Suite 120, Fishers, IN, 46038

    Description

    Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only).

    Reason

    The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

    Action

    "U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.

    Distribution

    Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

    Quantity

    564,310 in US and Canada plus 11,800 outside N. America