BEUDAMED
    FDA Recall Terminated

    Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

    Recall: Z-2203-2019 · Initiated April 25, 2019

    Recall

    Recall Number
    Z-2203-2019
    Event Number
    83323
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    MNL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 25, 2019
    Terminated
    December 16, 2020
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

    Reason

    Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.

    Action

    On April 25, 2019, the firm sent Additional Items - Lots Affected URGENT RECALL MEDLINE INDUSTRIES IMMEDIATE ACTION REQUIRED letters to 61 consignees advising them of the problem, requesting that they apply stickers to any subject item/lot, and return the Verification Form. On May 15, 2019, the firm sent out a second recall letter to 36 consignees.

    Distribution

    US Nationwide distribution in the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KY, LA, MO, NC, NH, NJ, NM, NY, NV, OH, OK, PA, RI, TN, TX, UT, WV, and WY

    Quantity

    22204