BEUDAMED
    FDA Recall Terminated

    Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. Used for temporary internal drainage from the ureteropelvic junction to the bladder.

    Recall: Z-0852-2011 · Initiated October 18, 2010

    Recall

    Recall Number
    Z-0852-2011
    Event Number
    57352
    Firm
    Vance Products Incorporated
    FEI Number
    1825146
    Product Code
    FAD
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    October 18, 2010
    Posted
    January 5, 2011
    Terminated
    July 27, 2011
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. Used for temporary internal drainage from the ureteropelvic junction to the bladder.

    Reason

    The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong.

    Action

    The firm sent URGENT: RECALL NOTICES dated 10/18/2010 to its direct accounts. The notice identified the affected product and instructed firms to pull the recalled product from stock and isolate it. Customers are to complete the form and e-mail or fax the form back to Cook. Product should be returned to the recalling firm using the Return Goods Authorization number. Cook Urological will credit customer accounts upon receipt of the returned product.

    Distribution

    Worldwide Distribution -- USA, including states of WI, TX, NY, SC, AZ, TN, FL, AR, CA, AL, and WA and country of Canada.

    Quantity

    25 units