BEUDAMED
    FDA Recall Terminated

    Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case.

    Recall: Z-1042-05 · Initiated June 22, 2005

    Recall

    Recall Number
    Z-1042-05
    Event Number
    32525
    Firm
    Core Brands
    FEI Number
    3004823187
    Product Code
    LCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2005
    Posted
    July 22, 2005
    Terminated
    November 16, 2005
    Address
    1301 Wicomico Street, Baltimore, MD, 21230-2000

    Description

    Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case.

    Reason

    Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.

    Action

    The recalling firm notified distributors by phone on 06/17/05 to hold product and followed with a letter and fax to distributors and direct account retailers on 06/21/05. Notification instructed distributors and retailers to discontinue selling the product and return product. Distributors were requested to notify all of their consignees with the 'retailer alert' notification provided.

    Distribution

    Product was sold to distributors and retailers in MI, NY, MD, MA, PA, NJ and RI..

    Quantity

    2710 cases