BEUDAMED
    FDA Recall Terminated

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    Recall: Z-1450-2015 · Initiated March 9, 2015

    Recall

    Recall Number
    Z-1450-2015
    Event Number
    70829
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 9, 2015
    Posted
    April 16, 2015
    Terminated
    February 1, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    Reason

    Internal gas line may malfunction causing the line to burst under pressure.

    Action

    CooperSurgical sent an Recall letter dated March 13, 2015, shipped via Fedex with confirmed delivery receipt. The letter identified the product the problem and the action needed to be taken by the customer. No adverse events or injuries have been reported to date in connection to this recall. As stated above, the risks associated with the use of this product involve the potential for a hose to burst while under pressure. The potential hazard associated with the failure mode is negligible; there is no foreseen adverse event due to this failure mode. The event was discovered internally during an investigation. Please complete the attached Acknowledgement and Receipt Form to make repair arrangements. If you have any further questions please feel free to contact me at 203.601.5200 Monday through Friday 8:00am to 5:00pm EST.

    Distribution

    Worldwide Distribution - Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WV,. and to the countries of : CANADA, COLOMBIA, EL SALVADOR, ENGLAND, GUATEMALA, HONG KONG, INDONESIA, SINGAPORE and ZIMBABWE.

    Quantity

    255 units