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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Event Detail

Event ID 67821
Product Type Devices
Status Ongoing
Recalling Firm Breg Inc
City Carlsbad
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-14
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support. Lot No. 705593 Class II 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. 2 units Z-1447-2014
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support. Lot No. 705764 Class II 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. 20 units Z-1446-2014
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