BEUDAMED
    FDA Recall Terminated

    Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40.

    Recall: Z-0525-2009 · Initiated August 18, 2008

    Recall

    Recall Number
    Z-0525-2009
    Event Number
    49100
    Firm
    Mainline Technology, Inc.
    FEI Number
    1000160426
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    August 18, 2008
    Posted
    January 15, 2009
    Terminated
    February 7, 2011
    Address
    3985 Research Park Dr, Ann Arbor, MI, 48108-2282

    Description

    Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40.

    Reason

    Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

    Action

    Consignees were notified via a Medical Device Removal Notice dated 8/18/08 to locate, discontinue use, and return product along with a copy of the letter. The recall was extended to an additional product via letter dated 9/5/08.

    Distribution

    Worldwide Distribution --- including USA and countries of Belgium and Switzerland.

    Quantity

    3713 kits