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Terminated

bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Recall Z-0503-2018 · Posted 2018-02-01

Recalling FirmBeaver-Visitec International Inc.
Recall StatusTerminated
Product CodeEMF
Date Initiated2017-11-03
Date Terminated2023-05-31
Product Quantity123,240 units

Reason for Recall

The protective shield was retracted, and the blade was exposed.

Firm Action

The firm disseminated their safety advisory notices on 11/03/2017 by email and visit. The letter identified the affected product, problem and actions to be taken. The firm requested the following action:"Prior to opening the Tyvek tray, please visually confirm that the plastic shield is not retracted and the activation slider is fully engaged."

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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