FDAClass IIJune 24, 2015

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the recall: Sterility Concern

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits

Why was BVI Custom Eyes¿ Ophthalmic Procedure Kits with the recalled?

Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product

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: 3039720 3046211 3047770 3049473 3070763 3082330 3089827 3093682 3095941 3106407 3117874

Product
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
Recalling firm
Beaver-Visitec International Inc.
Quantity
585 kits
Distribution
Nationwide Distribution including KY, GA, MI, and NJ.
Recall date
June 24, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls