BEUDAMED
    FDA Enforcement Class II Terminated

    Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

    Recall: Z-2129-2012 · Reported August 8, 2012

    Enforcement

    Recall Number
    Z-2129-2012
    Event ID
    62538
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2012
    Initiation Date
    April 17, 2012
    Classification Date
    August 2, 2012
    Termination Date
    August 23, 2012
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

    Reason

    The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

    Code Info

    Part Number 460730418 510(k) K052865 Lot number 2444750

    Distribution

    Nationwide distribution

    Quantity

    N/A