BEUDAMED
    FDA Recall Terminated

    Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.

    Recall: Z-0900-05 · Initiated December 3, 2004

    Recall

    Recall Number
    Z-0900-05
    Event Number
    31878
    Firm
    HK Surgical Inc
    FEI Number
    1000125732
    Product Code
    FIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 3, 2004
    Posted
    June 17, 2005
    Terminated
    April 19, 2012
    Address
    30280 Rancho Viejo Rd, San Juan Capistrano, CA, 92675-1561

    Description

    Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.

    Reason

    Risk of hubs becoming disconnected from the cannula.

    Action

    Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.

    Distribution

    Nationwide, Saudi Arabia, New Zealand, Phillipines, Switzerland, Canada, Netherlands, Taiwan, Germany, Japan, Malaysia, United Kingdom, Indonesia, Austria, Belgium, Puerto Rico, England.

    Quantity

    To be determined