FDA-Device2018-02-07Class II
bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Beaver-Visitec International Inc.
Hazard
The protective shield was retracted, and the blade was exposed.
Sold states
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Affected count
526,220 units
Manufactured in
411 Waverley Oaks Rd Ste 229, Waltham, MA, United States
Products
bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2018Don't want to check this manually?
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