FDAClass IIApril 13, 2016

Ellex Medical Fixed eye Safety filters recall

Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter…

Why was Ellex Medical Fixed eye Safety filters recalled?

The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.

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?

Model Number : 3143270

Product
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter…
Recalling firm
Laserex Systems Inc.
Quantity
72 units plus 2 spare units
Distribution
Worldwide Distribution - US Distribution
Recall date
April 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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