Medical device recalls Moderate risk

Beaver-Visitec International Inc. recalls BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgica…

Recall date
May 1, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1802-2015
FDA classification
Class II
Brand / firm
Beaver-Visitec International Inc.
Sold / distributed
Nationwide Distribution including KY, GA, MI, and NJ.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits

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