Recall Z-1446-2014— Breg Inc
Class II · Terminated
Class II FDA medical device recall by Breg Inc, initiated 2014-03-14, terminated 2014-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.. Reason: Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label..
- Recalling firm
- Breg Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-14
- Terminated
- 2014-04-14
- Firm location
- Carlsbad, CA, United States
Product description
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
Reason for recall
Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.