FDA recall Z-0500-2018

Product

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.

Reason for recall

The protective shield was retracted, and the blade was exposed.

Distribution

Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey

Key facts

Status

Terminated

Initiation date

2017-11-03

Report date

2018-02-07

Termination date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2018