BEUDAMED
    FDA Recall Terminated

    Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

    Recall: Z-1370-2019 · Initiated April 22, 2019

    Recall

    Recall Number
    Z-1370-2019
    Event Number
    82795
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    KOB
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 22, 2019
    Terminated
    May 5, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

    Reason

    Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.

    Action

    Cook issued MEDICAL DEVICE CORRECTION letters via courier to US Consignees on April 22, 2019. The letter provides reason for recall, products affected, health risk, action to take: Understand that stent knotting is a potential complication associated with use of the Kwart Retro-Inject" Stent Set and Salle Intraoperative Pyeloplasty Stent Set and should be considered if significant resistance is encountered during attempts at removal. 2. Please maintain a copy of this notice with the current IFU or product(s) in your inventory. 3. If you have affected product in inventory, you may continue to use these products. Cook Medical is not requesting product be returned. 4. Complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter.5. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected products have been transferred. Questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235

    Distribution

    Nationwide Foreign: Australia Canada Austria Belgium Denmark Germany Spain Finland France Martinique French Polynesia Switzerland Ireland Italy Netherlands Poland Sweden United Kingdom Hong Kong New Zealand Chile Colombia Israel Russian Federation Czech Republic Greece Jordan Slovakia South Africa United Arab Emirates Slovenia Lithuania Morocco Romania Qatar Bulgaria Libya Saudi Arabia Turkey Ukraine Thailand

    Quantity

    3711