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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.

FDA Recall Z-2590-2020 · Posted 2020-07-13

Recalling FirmDJO, LLC
Recall StatusTerminated
Product CodeIMF
Date Initiated2018-06-25
Date Terminated2022-11-15
Product Quantity41,801 units

Reason for Recall

The device accessories were not labeled with appropriate latex warning.

Firm 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

Root Cause

Process change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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