PlainRecalls
FDA Devices Moderate Class II Terminated

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits

Reported: June 24, 2015 Initiated: May 1, 2015 #Z-1806-2015

Product Description

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits

Reason for Recall

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

Details

Units Affected
268 kits
Distribution
Nationwide Distribution including KY, GA, MI, and NJ.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits. Recalled by Beaver-Visitec International Inc.. Units affected: 268 kits.
Why was this product recalled?
Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
Which agency issued this recall?
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1806-2015.