BEUDAMED
    FDA Recall Terminated

    Smiths Medical ASD, Inc. Regional Anesthesia Trays containing the Hospira 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) as follows: Product Number/Description 15248C-22/25 SPINAL TRAY 22/25 (SDD)W/DRUGS

    Recall: Z-1240-04 · Initiated July 2, 2004

    Recall

    Recall Number
    Z-1240-04
    Event Number
    29490
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 2, 2004
    Posted
    July 30, 2004
    Terminated
    May 2, 2006
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Smiths Medical ASD, Inc. Regional Anesthesia Trays containing the Hospira 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) as follows: Product Number/Description 15248C-22/25 SPINAL TRAY 22/25 (SDD)W/DRUGS

    Reason

    Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine Hydrochloride w/ 7.5% Dextrose lot number 09-568-DK). The drug is being recalled due to reports of particulate in the product.

    Action

    Smiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply Letter

    Distribution

    Nationwide

    Quantity

    300 units