BEUDAMED
    FDA Recall Terminated

    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.

    Recall: Z-1576-2011 · Initiated February 7, 2011

    Recall

    Recall Number
    Z-1576-2011
    Event Number
    57885
    Firm
    Remington Medical Inc.
    FEI Number
    1000132370
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 7, 2011
    Posted
    March 7, 2011
    Terminated
    August 12, 2011
    Address
    6830 Meadowridge Ct., Alpharetta, GA, 30005

    Description

    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.

    Reason

    There is a potential for the needle hubs to break during use.

    Action

    Remington Medical consignees were notified via facsimile, email and certified mail starting 02/07/2011. Distributors are requested to communicate this recall to their customers. If a customer does not respond to the recall notice within one week of the recall notification, the customer will be contacted by telephone. If this is unsuccessful, the customer will be sent a second Recall Notice letter and Customer Inventory Reconcile Fax by certified mail by 28 February 2011. If there is no response at that point, RMI will consider the customer's inventory depleted. All return product for this recall will follow RMIs Returns Goods Authorization procedure (SOP7-200). All product returns and customer responses will be documented. Upon completion of the recall, the status will be updated and submitted for the FDA's recall closure process.

    Distribution

    U.S. Nationwide

    Quantity

    10101 units