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.
FDA Recall Z-0504-2018 · Posted 2018-02-01
Recalling FirmBeaver-Visitec International Inc.
Recall StatusTerminated
Product CodeEMF
Date Initiated2017-11-03
Date Terminated2023-05-31
Product Quantity526,220 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The protective shield was retracted, and the blade was exposed.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.