BEUDAMED
    FDA Recall Terminated

    Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

    Recall: Z-0569-2018 · Initiated June 21, 2017

    Recall

    Recall Number
    Z-0569-2018
    Event Number
    78878
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    June 21, 2017
    Terminated
    April 3, 2018
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

    Reason

    B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.

    Action

    The firm, BD, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 6/12/2017 to its customers/kit packers. B.Braun Medical Inc. (BBMI), sent a "VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated 6/23/2017 to all BBMI customers in receipt of suspect product. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. The letters described the product, problem and actions to be taken. The customers were instructed to review the device notification in its entirety and inform all users of the recall; determine your inventory of the affected product-Do not destroy any affected product; complete and return the "Product Removal Acknowledgement" form to B.Braun Medical Inc. Quality Assurance department via fax to 610-849-1197 or email to [email protected] within two 2 weeks of receipt, even if the total inventory in your possession is zero 0; and if you have any full cases, partial cases or unused individual pieces a BBMI Customer Support Representative will contact you to provide instructions for handling affected product and arrange for return. Should you have any questions or concerns regarding the recall, please contact our Customer Support Department at 800-227-2862.

    Distribution

    US Nationwide Distribution.

    Quantity

    11,920 units