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U.S. Department of Health and Human Services

Class 2 Device Recall Knife, Opthalmic

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 Class 2 Recall
Knife, Opthalmic
see related information
Date Posted April 05, 2011
Recall Status1 Terminated on June 14, 2012
Recall Number Z-1894-2011
Recall Event ID 58109
Product Classification Knife, Ophthalmic - Product Code HNN
Product BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture.
Code Information Lot/serial number: 0333798
Recalling Firm/
Manufacturer
Beaver-Visitec International Inc.
411 Waverley Oaks Rd Ste 229
Waltham, Massachusetts 02452-8422
For Additional Information Contact Steven Bourdon
781-906-7917
Manufacturer Reason
for Recall
Loose blades in the handle of knives due to uncured epoxy.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Beaver Visitec International, Inc.sent an Urgent Recall Notification letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product and to complete a Customer Response Form (to be returned via fax to 866-906-4304. For questions regarding this recall call 781-906-7917.
Quantity in Commerce 1680 units (1130 domestic, 550 foreign)
Distribution Worldwide Distribution - USA including AZ, MA, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA and the country of China
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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