BEUDAMED
    FDA Recall Terminated

    Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac I.C. Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2557-000-10.

    Recall: Z-1496-2008 · Initiated January 29, 2008

    Recall

    Recall Number
    Z-1496-2008
    Event Number
    47233
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    GCY
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 29, 2008
    Posted
    September 19, 2008
    Terminated
    November 12, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac I.C. Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2557-000-10.

    Reason

    The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.

    Action

    Consignees were notified via recall letter dated 1/29/08 to locate and return the affected product. The recall action was expanded to additional products/lots via recall letter dated 3/17/08. Custom kit packers were instructed to notify their customers.

    Distribution

    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.

    Quantity

    102,813 mini-hemovac systems