BEUDAMED
    FDA Recall 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 · Initiated August 7, 2015

    Recall

    Recall Number
    Z-2423-2015
    Event Number
    71911
    Firm
    International Biophysics Corp.
    FEI Number
    1000117854
    Product Code
    DWS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 7, 2015
    Posted
    August 19, 2015
    Terminated
    March 1, 2016
    Address
    2101 E Saint Elmo Rd, Bldg 2 Ste 275, Austin, TX, 78744-1015

    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.

    Action

    The recalling firm began notifying their affacted customers on 7/2/2015

    Distribution

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

    Quantity

    10,330 units