BEUDAMED
    FDA Recall Terminated

    Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.

    Recall: Z-1141-2021 · Initiated January 11, 2021

    Recall

    Recall Number
    Z-1141-2021
    Event Number
    87173
    Firm
    Ecolab Inc
    FEI Number
    3014342658
    Product Code
    PUI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 11, 2021
    Terminated
    January 9, 2023
    Address
    1 Ecolab Pl, Saint Paul, MN, 55102-2739

    Description

    Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.

    Reason

    Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. This could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.

    Action

    The firm sent a recall communication letter "Urgent: MEDICAL DEVICE RECALL IMMEDIATE ATTENTION REQUIRED" to customers on 01/11/2021.

    Distribution

    Worldwide distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, HI, ID, IL, IN, KS, LA, MA, MD, MI, MO, MT, NJ, NY, OH, OK, OR, PA, TN, TX, UT, WA. In the country of Japan.

    Quantity

    132 cases (3168 drapes)