K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee suppor

FDA device recall Z-1447-2014 · posted 2014-04-10 · Terminated

Recall details

Recalling firm

Breg Inc

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.

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.

Root cause

Process change control

Status

Terminated

Product code

IQI

Quantity affected

2 units

Distribution

USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.

Date initiated

2014-03-14

Date posted

2014-04-10

Date terminated

2014-04-14

Location

Carlsbad, CA