BEUDAMED
    FDA Recall Terminated

    Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021

    Recall: Z-1148-06 · Initiated May 22, 2006

    Recall

    Recall Number
    Z-1148-06
    Event Number
    35491
    Firm
    United States Surgical
    FEI Number
    1219930
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 22, 2006
    Posted
    June 17, 2006
    Terminated
    December 12, 2007
    Address
    195 McDermott Rd, North Haven, CT, 06473-3665

    Description

    Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021

    Reason

    The 9F device may contain a 10 F sheath instead of the 9F

    Action

    United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.

    Distribution

    Nationwide and International Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec

    Quantity

    63 UNITS