BEUDAMED
    FDA Recall Terminated

    Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)

    Recall: Z-0935-03 · Initiated May 13, 2003

    Recall

    Recall Number
    Z-0935-03
    Event Number
    26324
    Firm
    Sanarus Medical Inc
    FEI Number
    3003515897
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2003
    Posted
    June 12, 2003
    Terminated
    September 15, 2003
    Address
    5880 West Las Positas, Suite 52, Pleasanton, CA, 95488

    Description

    Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)

    Reason

    Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.

    Action

    On 5/13/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

    Distribution

    Product was released for distribution to 10 consignees. 83 units from the lot had been shipped to consignees. The U.S. States include: MD, TN, TX, OH, and IL. The recall was appropriately extended to the user level; i.e., clinics, hospitals and medical centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

    Quantity

    83 units