BEUDAMED
    FDA Recall Terminated

    Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.

    Recall: Z-1956-2009 · Initiated May 8, 2008

    Recall

    Recall Number
    Z-1956-2009
    Event Number
    50739
    Firm
    Genico, Inc., dba Genicon
    FEI Number
    3002590791
    Product Code
    GCY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 8, 2008
    Posted
    July 2, 2009
    Terminated
    October 1, 2009
    Address
    6869 Stapoint Ct, Ste 114, Winter Park, FL, 32792-6603

    Description

    Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.

    Reason

    Genicon is recalling the Genicon Disposable Suction Irrigation 5mm 700-005-010 and 10mm 700-005-005 Tube Sets. The caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the Suction Irrigation Device.

    Action

    All four consignees were contacted by email and fax on May 8, 2008. Wholesalers were requested to forward copies of Genicon's recall letter dated May 8, 2009 and response form to their customers. Instructions for product return was provided. Direct questions about the recall to Genicon by calling 407-657-4851 (in United States) or 0118 930 5333 (in United Kingdom).

    Distribution

    Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.

    Quantity

    2,790