BEUDAMED
    FDA Recall Terminated

    Port-A-Cath II Epidural Low Profile Polysulfone/Titanium Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 5mm I.D., REF 21-1501-22

    Recall: Z-0857-04 · Initiated March 29, 2004

    Recall

    Recall Number
    Z-0857-04
    Event Number
    28667
    Firm
    Deltec, Inc
    FEI Number
    2183502
    Product Code
    MDV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 29, 2004
    Posted
    July 20, 2004
    Terminated
    December 28, 2006
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Port-A-Cath II Epidural Low Profile Polysulfone/Titanium Access System, with PolyFlow Polyurethane Catheter, 1.2mm O.D. x 5mm I.D., REF 21-1501-22

    Reason

    Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.

    Action

    A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.

    Distribution

    The recalled products were shipped nationwide in the United States and worldwide.