BEUDAMED
    FDA Recall Terminated

    Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028

    Recall: Z-0834-06 · Initiated March 22, 2006

    Recall

    Recall Number
    Z-0834-06
    Event Number
    35184
    Firm
    Fresenius Medical Care North America
    FEI Number
    3001451489
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2006
    Posted
    May 3, 2006
    Terminated
    July 11, 2006
    Address
    95 Hayden Avenue, Lexington, MA, 02421-7942

    Description

    Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028

    Reason

    Stay safe trigger body may not connect to the extension set and result in associated peritonitis

    Action

    Fresenius Medical notified customers by telephone on 3/24/06 for initial lots recalled and followed by letter dated 3/30/06 to include all lots numbers recalled.

    Distribution

    Nationwide Canada

    Quantity

    141,770 units