Medical device recalls Moderate risk

Beaver-Visitec International Inc. recalls bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233…

Recall date
November 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0500-2018
FDA classification
Class II
Brand / firm
Beaver-Visitec International Inc.
Sold / distributed
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey

Why it was recalled

The protective shield was retracted, and the blade was exposed.

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 Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

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