Class 2 Device Recall Beaver XStar

• Date Initiated by Firm: June 18, 2018
• Create Date: August 09, 2018
• Recall Status: Terminated on October 30, 2019
• Recall Number: Z-2740-2018
• Recall Event ID: 80565
• Product Classification: ophthalmic surgical instrument - Product Code HNN
• Product: Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
• Code Information: Lot Number 6001700
• FEI Number: 1211998
• Recalling Firm/ Manufacturer: Beaver Visitec; 500 Totten Pond Rd; 10 City Point; Waltham MA 02451-1916
• For Additional Information Contact: Max Cox; 781-906-7950
• Manufacturer Reason for Recall: Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
• FDA Determined Cause: Packaging process control
• Action: BVI issued PRODUCT RECALL NOTICES to customers dated June 11, 2018. Customers were instructed to inspect stock, quarantine and destroy product per internal procedures. BVI is kindly asking the customers to provide objective evidence of product destruction so that a credit can be applied to accounts. Customers are also encouraged to complete and return the response form. If you have questions regarding this recall please call Customer Service at 866-906-8080.
• Quantity in Commerce: 440
• Distribution: Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel
• 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.