FDAClass IIJuly 9, 2014

Alcon CUSTOM-PAK containing Anterior Chamber Cannula recall

Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and…

Why was Alcon CUSTOM-PAK containing Anterior Chamber Cannula recalled?

Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle

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?

Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H.

Product
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and…
Recalling firm
Alcon Research, Ltd.
Quantity
684 total (525 units in US)
Distribution
Nationwide Distribution including North Carolina and Maine
Recall date
July 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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