Class 2 Device Recall Haylard

• Date Initiated by Firm: August 10, 2026
• Date Posted: October 07, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0095-2027
• Recall Event ID: 99808
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04
• Code Information: 1. Model/Item Number (Kit): VAPX014-04; UDI-DI: 10809160332863; Kit Lot Numbers: 1701106, 1702175, 1702273; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU4043
• FEI Number: 1047429
• Recalling Firm/ Manufacturer: AVID Medical, Inc.; 9000 Westmont Dr; Toano VA 23168-9351
• For Additional Information Contact: Marlene Jones; 470-280-4277
• Manufacturer Reason for Recall: Product may be potentially contaminated with a lubricant used during the manufacturing process.
• FDA Determined Cause: Process change control
• Action: On August 10, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, segregate, and quarantine all Avid kits identified in Attachment 1. 2. Add recall labels to affected Avid kits to ensure all users are aware of the actions to discard the impacted component. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. - Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. -Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.
• Quantity in Commerce: 33
• Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
• 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.