BEUDAMED
    FDA Recall Terminated

    8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.

    Recall: Z-0055-2012 · Initiated August 1, 2011

    Recall

    Recall Number
    Z-0055-2012
    Event Number
    59526
    Firm
    Angiodynamics, INC
    FEI Number
    3017892510
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 1, 2011
    Posted
    October 13, 2011
    Terminated
    March 7, 2012
    Address
    1 Horizon Way, Manchester, GA, 31816-1749

    Description

    8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.

    Reason

    The product may contain an incorrect size catheter and introducer.

    Action

    AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011. The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF). For question on this recall contact AngioDynamics, Inc at (800) 772-6446.

    Distribution

    (USA) Nationwide distribution including the states of CA, FL, GA, IA, IL, IN, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, TN, UT, WA and WI.

    Quantity

    1095 total units