Class 2 Device Recall BVI CustomEyes Procedure Packs

• Date Initiated by Firm: July 26, 2024
• Date Posted: August 28, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2825-2024
• Recall Event ID: 95068
• Product Classification: Kit, surgical instrument, disposable - Product Code KDD
• Product: BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000789
• Code Information: Part Number: 58000789; UDI-DI: 30886158020395; Lot/Batch Number: 6048500, 6049553
• Recalling Firm/ Manufacturer: Beaver Visitec International, Inc.; 500 Totten Pond Rd; 10 City Point; Waltham MA 02451-1916
• For Additional Information Contact: Agnieszka Drzewiecka; 781-906-7950
• Manufacturer Reason for Recall: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
• FDA Determined Cause: No Marketing Application
• Action: On July 27, 2024 URGENT FIELD SAFETY NOTICE letters were sent to consignees. Actions required of you 1. Please immediately determine if any of the affected CustomEyes Procedure Packs are within your facility. In such case, quarantine them, and discontinue use until correct recall labels are applied. Please refer to Appendix 1 CustomEyes Procedure Packs List 2. If you have further distributed this product, please notify your customers by initiating a subrecall. 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. 3. Please follow the attached instructions for placing the recall labels on the products containing Sol-M syringes, which inform the users to not use the affected syringes. If additional recall labels are needed, contact bvi2958@sedgwick.com. Product may be returned to inventory once properly over-labeled. Refer to Appendix 2 Over labeling Instructions 4. At the point of clinical use, the Sol-M syringes are to be discarded. Photographs of Sol-M syringes are enclosed to assist in identification. Appendix 3 Images 5. Ensure that appropriate personnel within your organization are made aware of this field action 6. To maintain awareness, we suggest to post this URGENT MEDICAL DEVICE RECALL NOTICE and Sol-M syringe photographs on or near the affected products in your inventory location 7. Please fill out, scan and email the completed Business Response Form to BVI Sedgwick at bvi2958@sedgwick.com within seven (7) days BVI is committed to providing high quality products to you and apologizes for any inconvenience this field action may cause. If you have any questions, please reach out to your Sales Representative.
• Quantity in Commerce: 260 units
• Distribution: US Nationwide distribution.
• 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.