BEUDAMED
    FDA Recall Terminated

    PhaSeal, Protector 50, Item No. 50, US Order No. 10310

    Recall: Z-1181-2007 · Initiated June 26, 2007

    Recall

    Recall Number
    Z-1181-2007
    Event Number
    38251
    Firm
    Carmel Pharma, Inc.
    FEI Number
    3002897967
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 26, 2007
    Posted
    August 22, 2007
    Terminated
    March 5, 2013
    Address
    7029 Huntley Road, Suite O, Columbus, OH, 43229

    Description

    PhaSeal, Protector 50, Item No. 50, US Order No. 10310

    Reason

    Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.

    Action

    On or about 6/15/2007, the firm sent advisory notice letters to the end users and the instructions for use have been updated by adding a precaution statement regarding the use of thick rubber stoppers. The firm is also updating the customer training program to include how to handle drug vials with thick concave rubber stoppers.

    Distribution

    Product was distributed throughout the US and Canada

    Quantity

    6.1 million for Z-1178-1181-2007 recalls