—#160527

Product

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 product code: EMF — Knife, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Batch Numbers: 3180336 3181395 3183925 3184461 3183518 3187183 3187940 3189616 3190463 3192521 3193360 3194101 3199801 3200589 3201368 3201959 3202091 3202764 3203228 3204381 3205075 3205511 3205828 3207499 3208102 3211276 3215327 3218819 3218144 3220074 3221091 3221092 3223818 3223055 3223115 3224020 3225234

Why it was recalled

The protective shield was retracted, and the blade was exposed.

Root cause (FDA determination)

Process control

Action the firm took

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."

Recalling firm

Firm: Beaver-Visitec International Inc.
Address: 411 Waverley Oaks Rd, Ste 229, Waltham, Massachusetts 02452-8422

Distribution

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

Timeline

Recall initiated: 2017-11-03
Posted by FDA: 2018-02-01
Terminated: 2023-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160527. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.