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.
This recall has been terminated (originally issued February 1, 2018).
- Recall Initiated
- November 3, 2017
- Posted
- February 1, 2018
- Terminated
- May 31, 2023
- Recall Number
- Z-0500-2018
- Quantity
- 45, 680 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
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The protective shield was retracted, and the blade was exposed.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
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
Root Cause
Process control
Action Taken
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."