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: 584569 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: 3035614 3046205 3052693 3055885 3063181 3068806 3073917 3082315
- Product
- BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
- Recalling firm
- Beaver-Visitec International Inc.
- Quantity
- 621 kits
- Distribution
- Nationwide Distribution including KY, GA, MI, and NJ.
- Recall date
- June 24, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)