BEUDAMED
    FDA Recall Terminated

    Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063

    Recall: Z-0715-06 · Initiated February 17, 2006

    Recall

    Recall Number
    Z-0715-06
    Event Number
    34859
    Firm
    Rubicor Medical
    FEI Number
    3004014191
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 17, 2006
    Posted
    April 11, 2006
    Terminated
    May 11, 2006
    Address
    600 Chesapeake Drive, Redwood City, CA, 94063-1712

    Description

    Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063

    Reason

    Devices' sterility may be compromised due to lack of adequate sterilization.

    Action

    On 2/17/06, the firm initiated the recall and its notification was via sales rep retrieval and follow-up letter dated 3/13/06 explaining the reason for the recall and requesting the product be returned.

    Distribution

    Nationwide. The product was released for distribution to 19 consignees in US. The firm''s sales force were able to retrieve 18 units, only one (1) was used by a consignee. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, physicians who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

    Quantity

    19 units