Recall Z-1446-2014 ยท IQI Orthosis, Limb Brace
Breg Inc
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
| Date | Apr 10, 2014 (initiated Mar 14, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | Breg representatives informed customers of the recall by telephone on March 14, 2014 and then a customer notification letter was sent to customers via email onMarch 17, 2014. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the return response form. Customers with questions are instructed to contact Breg Customer Care at (800) 321-0607. |
| Quantity | 20 units |
| Distribution | USA Nationwide Worldwide in the states of: TX, KY, IN, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.