bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used fo
FDA device recall Z-0503-2018 · posted 2018-02-01 · Terminated
Recall details
- Recalling firm
- Beaver-Visitec International Inc.
- Reason for recall
- The protective shield was retracted, and the blade was exposed.
- 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."
- Root cause
- Process control
- Status
- Terminated
- Product code
- EMF
- Quantity affected
- 123,240 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
- Date initiated
- 2017-11-03
- Date posted
- 2018-02-01
- Date terminated
- 2023-05-31
- Location
- Waltham, MA
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