FDA-Device2015-06-24Class II

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits

Beaver-Visitec International Inc.
Hazard

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

Sold states
Nationwide Distribution including KY, GA, MI, and NJ.
Affected count
214 kits
Manufactured in
411 Waverley Oaks Rd Ste 229, Waltham, MA, United States
Products
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1805-2015

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