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Recall Observatory FDA recall evidence

Device product

Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.

Z-1446-2014

March 14, 2014

Class II

Product summary

Firm
Breg Inc
Event
Event 67821
Status
Terminated
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-1446-2014

Official wording

Reason: 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.

Code information: Lot No. 705764

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.