BEUDAMED
    FDA Recall Terminated

    Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.

    Recall: Z-0980-2009 · Initiated November 10, 2008

    Recall

    Recall Number
    Z-0980-2009
    Event Number
    50223
    Firm
    Vance Products Incorporated
    FEI Number
    1825146
    Product Code
    FAD
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 10, 2008
    Posted
    February 10, 2009
    Terminated
    November 25, 2009
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.

    Reason

    "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.

    Action

    Consignees were notified via recall letter, "Urgent: Recall Notice" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS.

    Distribution

    Nationwide Distribution including states of Georgia, Oregon and Texas.

    Quantity

    23