FDAClass IIDecember 17, 2014

Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps recall

Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501…

Why was Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps recalled?

The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

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?

Lot numbers 061814-95 and 080614-91

Product
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501…
Recalling firm
Alcon Research, Ltd.
Quantity
2321
Distribution
Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
Recall date
December 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls