BEUDAMED
    FDA Recall Terminated

    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.

    Recall: Z-2590-2020 · Initiated June 25, 2018

    Recall

    Recall Number
    Z-2590-2020
    Event Number
    85445
    Firm
    DJO, LLC
    FEI Number
    2020737
    Product Code
    IMF
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 25, 2018
    Posted
    July 13, 2020
    Terminated
    November 15, 2022
    Address
    3151 Scott St, Vista, CA, 92081-8365

    Description

    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.

    Reason

    The device accessories were not labeled with appropriate latex warning.

    Action

    The firm's initial notification was sent to consignees on June 25, 2018. On August 14, 2020 the firm sent an additional "Urgent: Safety Alert" email to affected customers. In addition to informing consignees about the recall, the firm requested consignees take the following actions: 1. if you have any of the products listed in the product list attached to the letter, please discontinue the use of that product and discard it. 2. DJO Global is recommending that, in a timely manner, you send a notification to all customers who have purchased or were issued the affected products from you. 3. Please select the Click Here to Respond button below as soon as possible to complete your response

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and WV The countries of Algeria, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Congo, Congo, The Democratic Republic of the, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, England, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Republic of, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam.

    Quantity

    41,801 units