BEUDAMED
    FDA Recall Terminated

    Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599" Intended for use in cardiopulmonary bypass procedures.

    Recall: Z-0193-2010 · Initiated September 25, 2009

    Recall

    Recall Number
    Z-0193-2010
    Event Number
    53543
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    KFM
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    September 25, 2009
    Posted
    November 13, 2009
    Terminated
    December 14, 2009
    Address
    14401 W 65th Way, Arvada, CO, 80004

    Description

    Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599" Intended for use in cardiopulmonary bypass procedures.

    Reason

    A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.

    Action

    Customers were notified by an Urgent: Field Safety Notice, dated 9/25/09, and instructed to: check their inventory for the affected product, complete the customer response form and return or visually inspect all affected product before use. For additional information contact Sorin Group Customer Service at 1-800-650-2623.

    Distribution

    Worldwide Distribution -- US, Canada, Japan, and Europe.

    Quantity

    256 units