BEUDAMED
    FDA Recall 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 · Initiated April 21, 2015

    Recall

    Recall Number
    Z-1610-2015
    Event Number
    71057
    Firm
    Zimmer Surgical Inc
    FEI Number
    1526350
    Product Code
    GCY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 21, 2015
    Posted
    May 13, 2015
    Terminated
    November 6, 2015
    Address
    200 W Ohio Ave, Dover, OH, 44622-9642

    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.

    Action

    On 4/28/2015 the firm sent Urgent: Medical Device Removal letters to their customers. The letters identified the affected product in addition to stating that the reason for the recall is due to missing Instructions for Use from sales units. The letters discussed the clinical implications or risk to health, and actions required. Customers are to review the notification, identify and quarantine the affected product to prevent further distribution or use, and return the completed response form to [email protected] and the affected product to the address provided. A credit will be issued for unused devices upon receipt. Questions regarding this information should be directed to 330-364-0989.

    Distribution

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

    Quantity

    36 units