Class 2 Device Recall Vista Dental Products Sodium Hypochlorite 6

• Date Initiated by Firm: June 27, 2019
• Date Posted: October 01, 2019
• Recall Status: Terminated on August 10, 2021
• Recall Number: Z-0014-2020
• Recall Event ID: 83435
• 510(K)Number: K082470
• Product Classification: Cleanser, root canal - Product Code KJJ
• Product: Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
• Code Information: UDI (01)10818207020458 Lot/Work Order Numbers: 20190197 20190723 20190834 20190862 20190952
• Recalling Firm/ Manufacturer: Inter-Med Llc; 2200 Northwestern Ave; Racine WI 53404-2500
• For Additional Information Contact: Katy Scott; 414-639-9755
• Manufacturer Reason for Recall: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
• FDA Determined Cause: Process control
• Action: The firm initiated the recall by letter on 06/27/2019. The letter directed the consignee to quarantine the product and contact the returns department for return instructions.
• Quantity in Commerce: 768 units
• Distribution: US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
• 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 = KJJ