K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.
This recall has been terminated (originally issued April 10, 2014).
- Company
- Breg Inc
- Recall Initiated
- March 14, 2014
- Posted
- April 10, 2014
- Terminated
- April 14, 2014
- Recall Number
- Z-1447-2014
- Quantity
- 2 units
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
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.
Distribution
USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.
Lot / Code Info
Lot No. 705593
Root Cause
Process change control
Action Taken
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.