Recall Z-0504-2018 ยท EMF Knife, Surgical
Beaver-Visitec International Inc.
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.
| Date | Feb 1, 2018 (initiated Nov 3, 2017) |
| Status | Terminated |
| Reason | The protective shield was retracted, and the blade was exposed. |
| Root cause | Process control |
| 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." |
| Quantity | 526,220 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.