BEUDAMED
    FDA Recall Terminated

    Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20

    Recall: Z-0166-04 · Initiated October 10, 2003

    Recall

    Recall Number
    Z-0166-04
    Event Number
    27470
    Firm
    Portex Inc
    FEI Number
    1217052
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 10, 2003
    Posted
    November 27, 2003
    Terminated
    May 2, 2006
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20

    Reason

    Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.

    Action

    Portex notified consignees on 10/10/03 by letter issued by Federal Express. Distributors were asked to supply customer list to Portex or to notify their accounts with copy of the recall letter provided.

    Quantity

    2600 units