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Terminated

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

FDA Recall Z-1447-2014 · Posted 2014-04-10

Recalling FirmBreg Inc
Recall StatusTerminated
Product CodeIQI
Date Initiated2014-03-14
Date Terminated2014-04-14
Product Quantity2 units

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.

Firm 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.

Root Cause

Process change control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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