BEUDAMED
    FDA Enforcement Class III Terminated

    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.

    Recall: Z-1610-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1610-2015
    Event ID
    71057
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Surgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2015
    Initiation Date
    April 21, 2015
    Classification Date
    May 13, 2015
    Termination Date
    November 6, 2015
    Address
    200 W Ohio Ave, N/A, Dover, OH, 44622-9642, United States

    Description

    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.

    Reason

    Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.

    Code Info

    Item #00-2568-000-10; Lot #62800843

    Distribution

    Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.

    Quantity

    36 units