BEUDAMED
    FDA Recall Terminated

    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia

    Recall: Z-1666-2014 · Initiated April 3, 2014

    Recall

    Recall Number
    Z-1666-2014
    Event Number
    68040
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    BSP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 3, 2014
    Posted
    May 28, 2014
    Terminated
    December 2, 2014
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia

    Reason

    B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.

    Action

    B/Braun sent an Urgent Medical Device Recall Notification letter dated April 3, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Device Recall Notification in its entirety and ensure that all users in their organization and other concerned persons are informed about this voluntary product recall. The letter should also be forwarded to their customers. Customers were instructed to determine their current inventory of the affected lots within their facility, DO NOT DESTROY ANY AFFECTED PRODUCT. Further use of the affected product should be discontinued immediately and quarantined. Customers should use the attached Product Removal Acknowledgement form to record the total number of inidividual units. If cusotmers have no remaining inventory they should check the box indicating zero inventory. Return the completed Product Removal Acknowledgement form to BBMI Quality Assurance department by fax to 610-849-1197 or email to [email protected] within 2 weeks of receipt, even if the inventory is zero (0). If customers have any affected product they should call BBMI Customer Support Department at 800-227-2862 to arrange for return and replacement product. Customers with questions were instructed to call the Clinical and Technical Support Department at 1-800-854-6851. For questions regarding this recall call 610-596-2870.

    Distribution

    Worldwide Distribution - USA (nationwide) and to Canada.

    Quantity

    7400