BEUDAMED
    FDA Recall Terminated

    Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; Article #67094S

    Recall: Z-2486-2010 · Initiated August 6, 2010

    Recall

    Recall Number
    Z-2486-2010
    Event Number
    56498
    Firm
    Medela Inc
    FEI Number
    1419937
    Product Code
    HGX
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 6, 2010
    Posted
    September 24, 2010
    Terminated
    September 7, 2011
    Address
    1101 Corporate Dr, Mchenry, IL, 60050-7006

    Description

    Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; Article #67094S

    Reason

    The product sterility may be compromised due to possible pinholes in the rigid tray of the package.

    Action

    Medela sent Important Device Recall letters dated August 6, 2010 to all direct accounts, identifying the affected product, the labeling issue, and actions to be taken by the customer. The accounts were informed that the sterility of the affected products may be compromised due to holes in the packaging. They were instructed to stop use, sale and distribution of the kits and return their stocks to Stericycle using the enclosed packing slip and prepaid UPS Return Service shipping label. The accounts were requested to complete and return the enclosed postage paid reply card, indicating the amount of product being returned. Distributors were requested to notify their customers. Questions about the recall process may be directed to Stericycle at 1-877-247-9970. Information on the recall is posted on Medela's website www.medelabreastfeedingus.com

    Distribution

    Worldwide Distribution: Nationwide throughout USA, including Guam, and to the countries of Barbados, Bermuda, British West Indies, Canada, Panama, Switzerland, Trinidad and Tobago, and Uganda.

    Quantity

    1,293,304 kits