Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall bvi Beaver EdgeAhead Safety Knife

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall bvi Beaver EdgeAhead Safety Knifesee related information
Date Initiated by FirmNovember 03, 2017
Date PostedFebruary 01, 2018
Recall Status1 Terminated 3 on May 31, 2023
Recall NumberZ-0500-2018
Recall Event ID 78789
Product Classification Knife, surgical - Product Code EMF
Productbvi 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.
Code Information (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 
Recalling Firm/
Manufacturer		 Beaver-Visitec International Inc.
411 Waverley Oaks Rd Ste 229
Waltham MA 02452-8422
For Additional Information Contact
781-906-7950
Manufacturer Reason
for Recall		The protective shield was retracted, and the blade was exposed.
FDA Determined
Cause 2		Process control
ActionThe 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 in Commerce45, 680 units
DistributionWorldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-