Recall Z-2590-2020 ยท IMF Unit, Chilling
DJO, LLC
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.
| Date | Jul 13, 2020 (initiated Jun 25, 2018) |
| Status | Terminated |
| Reason | The device accessories were not labeled with appropriate latex warning. |
| Root cause | Process change control |
| 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. |
| Quantity | 41,801 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.