BEUDAMED
    FDA Recall Terminated

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    Recall: Z-1654-2013 · Initiated March 18, 2013

    Recall

    Recall Number
    Z-1654-2013
    Event Number
    64888
    Firm
    Clorox Healthcare Holdings, LLC (dba HealthLink) 3611 Saint Johns Bluff Rd S Ste 1 Suite 1 Jacksonville FL 32224-2679
    FEI Number
    1000526105
    Product Code
    LRY
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    March 18, 2013
    Posted
    July 2, 2013
    Terminated
    February 25, 2014

    Description

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    Reason

    Due to lack of sterilization.

    Action

    On March 19, 2013, HealthLink sent their customers letters instructing them to do the following: 1) Screen their inventory and quarantine the product. 2) Notify all customers that received the affected products and ask them to return the lots to their firm. 3) Complete the attached form and return the lots to HealthLink Distribution center. For further assistance, customers were directed to call customer service at 1-800-638-2625.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.

    Quantity

    1,044,600 units