FDAClass IINovember 8, 2017

Alcon Custom Pak recall

Alcon Custom Pak

Why was Alcon Custom Pak recalled?

Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.

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?

2033459H, 2034186H, 2034491H

Product
Alcon Custom Pak
Recalling firm
Alcon Research, LTD.
Quantity
33 units
Distribution
States in the US - WI, NY, MO
Recall date
November 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls