Class 2 Device Recall Xstar Safety Slit Knife

• Date Initiated by Firm: May 10, 2024
• Date Posted: June 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2161-2024
• Recall Event ID: 94645
• Product Classification: Knife, ophthalmic - Product Code HNN
• Product: Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227
• Code Information: UDI-DI: 00886158001652; Lot Number: 6058854
• FEI Number: 1211998
• Recalling Firm/ Manufacturer: Beaver Visitec International, Inc.; 500 Totten Pond Rd; 10 City Point; Waltham MA 02451-1916
• Manufacturer Reason for Recall: The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
• FDA Determined Cause: Process control
• Action: An URGENT Field Safety Notice dated 5/10/24 was sent to customers. Actions Required by You Our records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots. PLEASE perform the following actions: 1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. In case you purchased the CustomEye Kit please be advised it is not possible to check the bevel orientation without losing the KIT sterility. In such case, immediately put the KIT out of use. 2. In case a non-conforming product is identified please quarantine it and return ALL quarantined product from the affected lots to our company via pre-paid postal labels, supplied to you with an initial notification 3. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 4. Review the enclosed Business Reply Form (BRF) and indicate whether you have the affected product in your possession. 5. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) destroyed. 6. Return the completed BRF to BVI by emailing the attached to bvi5577@sedgwick.com (U.S based customers) or to FA-24-002XstarOUS@Sedgwick.com (rest of the world based customers). BVI values your business and apologizes for the inconvenience this may have caused. Please direct any questions regarding credit to our customer service department by email and include in the subject line: Master Case PIR 00564835. Country Customer Service Email UK UKCustomerSupport@bvimedical.com FR serviceclient@bvimedical.com DE/ AT Kundendienst@bvimedical.com IT servizioclienti@bvimedical.com ROW ROWCustomerSupport@bvimedical
• Quantity in Commerce: 1300 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.