BEUDAMED
    FDA Enforcement Class II Terminated

    Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder

    Recall: Z-2971-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2971-2020
    Event ID
    86256
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 23, 2020
    Initiation Date
    July 30, 2020
    Classification Date
    September 15, 2020
    Termination Date
    November 4, 2021
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder

    Reason

    Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.

    Code Info

    Lot Number: 13060084

    Distribution

    International distribution to the country of Australia.

    Quantity

    20 units