BEUDAMED
    FDA Enforcement Class II Terminated

    Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures

    Recall: Z-2951-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2951-2018
    Event ID
    80740
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Haemonetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 5, 2018
    Initiation Date
    July 13, 2018
    Classification Date
    August 30, 2018
    Termination Date
    June 16, 2020
    Address
    400 Wood Rd, N/A, Braintree, MA, 02184-2412, United States

    Description

    Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures

    Reason

    OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.

    Code Info

    Lot # 1117066

    Distribution

    US Nationwide Distribution

    Quantity

    348 units