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U.S. Department of Health and Human Services

Class 2 Device Recall bvi Beaver Xstar Safety Slit Knife

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 Class 2 Device Recall bvi Beaver Xstar Safety Slit Knifesee related information
Date Initiated by FirmNovember 03, 2017
Date PostedFebruary 01, 2018
Recall Status1 Terminated 3 on May 31, 2023
Recall NumberZ-0503-2018
Recall Event ID 78789
Product Classification Knife, surgical - Product Code EMF
Productbvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Code Information Batch Numbers: 3180336 3181395 3183925 3184461 3183518 3187183 3187940 3189616 3190463 3192521 3193360 3194101 3199801 3200589 3201368 3201959 3202091 3202764 3203228 3204381 3205075 3205511 3205828 3207499 3208102 3211276 3215327 3218819 3218144 3220074 3221091 3221092 3223818 3223055 3223115 3224020 3225234 
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for Recall		The protective shield was retracted, and the blade was exposed.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 Commerce123,240 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.
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