FDAClass IIJune 3, 2015

Keo Brace recall

Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower…

Why was Keo Brace recalled?

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product # i-75100 Lot# AK20140801002

Product
Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower…
Recalling firm
United Surgical Associates
Quantity
756
Distribution
Domestic: HI International; None
Recall date
June 3, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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