BEUDAMED
    FDA Enforcement Class II Terminated

    IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.

    Recall: Z-2423-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2423-2015
    Event ID
    71911
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    International Biophysics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 26, 2015
    Initiation Date
    August 7, 2015
    Classification Date
    August 19, 2015
    Termination Date
    March 1, 2016
    Address
    Bldg 2, Ste 275, 2101 E Saint Elmo Rd, Austin, TX, 78744-1015, United States

    Description

    IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.

    Reason

    It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

    Code Info

    042415-3488, 022515-3372, 02215-3374, 022515-3372, 022515-3371, 022515-3373, 022515-3382, 022515-3383, 022515-3384, 022515-3385, 022515-3386, 040615-3452, 040615-3453, 040615-3449, 040615-3450, 040615-3451, 040615-3448, 040615-3447, 050815-3510, 050815-3509, 050815-3511, 050815-3512, 052715-3602, 060315-3603, 031215-3412, 022515-3387, 022515-3388, 033015-3442, 042415-3488

    Distribution

    Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa

    Quantity

    10,330 units