BEUDAMED
    FDA Recall Terminated

    Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA- (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).

    Recall: Z-0954-2007 · Initiated May 1, 2007

    Recall

    Recall Number
    Z-0954-2007
    Event Number
    37919
    Firm
    Possis Medical, Inc
    FEI Number
    2183460
    Product Code
    MCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 1, 2007
    Posted
    June 21, 2007
    Terminated
    July 15, 2007
    Address
    9055 Evergreen Blvd Nw, Minneapolis, MN, 55433-5833

    Description

    Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA- (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).

    Reason

    Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.

    Action

    Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form.

    Distribution

    Nationwide including states of AK, AR, AZ, CA, CT, FL,IL, IN, KY, MD, ME, MI, MN, MS, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, WA, and WI.

    Quantity

    69