BEUDAMED
    FDA Enforcement Class II 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 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1141-2021
    Event ID
    87173
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ecolab Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 3, 2021
    Initiation Date
    January 11, 2021
    Classification Date
    February 22, 2021
    Termination Date
    January 9, 2023
    Address
    1 Ecolab Pl, N/A, Saint Paul, MN, 55102-2739, United States

    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.

    Code Info

    Model ORS-320, lot D192619A, 132 cases (3168 drapes)

    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)