BEUDAMED
    FDA Recall Terminated

    AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

    Recall: Z-2096-2016 · Initiated June 1, 2016

    Recall

    Recall Number
    Z-2096-2016
    Event Number
    74301
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    June 1, 2016
    Posted
    July 22, 2016
    Terminated
    October 19, 2016
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

    AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

    Reason

    Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

    Action

    URGENT MEDICAL DEVICE RECALL RESTERILIZED ANGIODYNAMICS SOFT VU OMNI FLUSH ANGIOGRAPHIC CATHETER customer notification letters were sent 06/01/16. Customers were instructed to discontinue use of the recalled product immediately. Customers were told to complete the Recall Effectiveness Check Form and list the affected lots shipped to the facility. The form should be completed, signed, and returned to the local Stryker Sustainability Sales Representative, emailed to [email protected], or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ 85283 Attn: Jodie Rueckert Customers will receive a credit for all affected devices returned.

    Distribution

    Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA.

    Quantity

    167