BEUDAMED
    FDA Recall Terminated

    Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

    Recall: Z-2211-2017 · Initiated April 17, 2017

    Recall

    Recall Number
    Z-2211-2017
    Event Number
    77164
    Firm
    Madison Polymeric Engineering
    FEI Number
    3001451466
    Product Code
    LKB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 17, 2017
    Posted
    May 12, 2017
    Terminated
    September 21, 2017
    Address
    965 W Main St, Branford, CT, 06405-3453

    Description

    Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

    Reason

    Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.

    Action

    Cygnus Medical sent a first class letter dated April 14, 2017, indicating to discontinue use of HY0305Z Draco Pads with information to return the unused product also included. Our records indicate that you have purchased this lot number. Please check your inventory. The lot number can be found on the individual product pouch and the label on the carton. We have found a mold contaminant and request that you remove the product from use and return to us. We are conducting an investigation. To obtain a return authorization please contact our Quality Department. You may also contact our customer service at (800) 990-7489. We regret any inconvenience this may cause. Please contact Cygnus Medical LLC should you have any questions.

    Distribution

    Distributed in the US.

    Quantity

    5 cases