BEUDAMED
    FDA Recall Terminated

    1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin.

    Recall: Z-0174-2012 · Initiated June 15, 2011

    Recall

    Recall Number
    Z-0174-2012
    Event Number
    60255
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    KZH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 15, 2011
    Posted
    November 7, 2011
    Terminated
    July 27, 2015
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin.

    Reason

    Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.

    Action

    The firm, BD, sent an "PRODUCT RECALL NOTIFICATION" letter and response form dated June 15, 2011 to their consignee/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately review their inventory for the affected product, remove the product from inventory, quarantine the product and return it to BD; if the product was further distributed, they should identify their customers and notify them at once, and complete and return the attached Tracking/Verification Form via fax to: 201-847-4853. If you have any questions, contact Customer Service at 1-800-237-2762, Monday -Thursday, 8:00am-6:30pm and on Friday, 8:00-5:30pm Eastern Standard Time.

    Distribution

    Nationwide Distribution.

    Quantity

    10,230 shelf cartons (1,0230,000 syringes)