Recalls / —
—#160463
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.
- FDA product code
- EMF — Knife, Surgical
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- (a) REF 370531; Batch numbers: 3185248 3191981 3193837 3199247 3201734 3204737 3206382 3208096 3211720 3213361 3214546 3217371 3219431 3222626 3225976 (b) REF 378233; Batch numbers: 3191985 3204382 3225442
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The protective shield was retracted, and the blade was exposed.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 #160463. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.