BEUDAMED
    FDA Recall Terminated

    Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)

    Recall: Z-1899-2018 · Initiated March 21, 2018

    Recall

    Recall Number
    Z-1899-2018
    Event Number
    79826
    Firm
    Madison Polymeric Engineering
    FEI Number
    3001451466
    Product Code
    MNL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 21, 2018
    Terminated
    April 9, 2019
    Address
    965 W Main St, Branford, CT, 06405-3453

    Description

    Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)

    Reason

    The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

    Action

    Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following: 1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1. 2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us. 3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.

    Distribution

    The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.

    Quantity

    23 cases/1150 kits