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U.S. Department of Health and Human Services

Class 2 Device Recall Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415.

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 Class 2 Recall
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415.
see related information
Date Posted April 10, 2014
Recall Status1 Terminated on April 14, 2014
Recall Number Z-1446-2014
Recall Event ID 67821
Product Classification Orthosis, Limb Brace - Product Code IQI
Product Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
Code Information Lot No. 705764
Recalling Firm/
Manufacturer
Breg Inc
2885 Loker Ave E
Carlsbad, California 92010-6626
Manufacturer 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.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 20 units
Distribution USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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