Recall Z-2590-2020— DJO, LLC
Class II · Terminated
Class II FDA medical device recall by DJO, LLC, initiated 2018-06-25, terminated 2022-11-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- DJO, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-25
- Terminated
- 2022-11-15
- Firm location
- Vista, CA, United States
Product 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 for recall
The device accessories were not labeled with appropriate latex warning.
Data sourced from openFDA. This site is unofficial and independent of the FDA.