BEUDAMED
    FDA Enforcement Class II Terminated

    JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

    Recall: Z-0903-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0903-2020
    Event ID
    84183
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Haemonetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    October 21, 2019
    Classification Date
    January 29, 2020
    Termination Date
    November 6, 2020
    Address
    400 Wood Rd, N/A, Braintree, MA, 02184-2412, United States

    Description

    JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

    Reason

    Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

    Code Info

    Catalog number/FG Item Number: CSE-P-125-JA 1. No Specific Lots with Bowl Cracks (0 Distributed) 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.

    Quantity

    21113