Class 2 Device Recall Fugo Blade Incising Tip Assembly

• Date Initiated by Firm: April 28, 2006
• Date Posted: August 02, 2006
• Recall Status: Terminated on September 08, 2006
• Recall Number: Z-1224-06
• Recall Event ID: 35738
• 510(K)Number: K001498
• Product Classification: ophthalmic electrocautery - Product Code NCR
• Product: Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton.
• Code Information: Lot numbers 01013786, 01017917, 01017918, 01017684 and 01017442
• Recalling Firm/ Manufacturer: Medisurg Research & Management Corp; 100 W Fornance Street; The Fugo Building; Norristown PA 19401
• For Additional Information Contact: Dawn DelCampo; 610-277-3937
• Manufacturer Reason for Recall: No documentation to support shelf life/sterility
• FDA Determined Cause: Other
• Action: On 4/28/06, the recalling firm faxed a notification to the customers informing them not to use the product during surgery and to return the product.
• Quantity in Commerce: 960 tips
• Distribution: Nationwide, including CA, CT, FL, GA, MA, NC, NY, OH, OR, PA, TX, and WI.
• Total Product Life Cycle: TPLC 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.

• 510(K) Database: 510(K)s with Product Code = NCR