Class 2 Device Recall Cannon II Plus Replacement Hub Set

• Date Initiated by Firm: July 06, 2020
• Create Date: August 13, 2020
• Recall Status: Terminated on November 05, 2021
• Recall Number: Z-2802-2020
• Recall Event ID: 86044
• 510(K)Number: K020430
• Product Classification: Kit, repair, catheter, hemodialysis - Product Code NFK
• Product: Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
• Code Information: Product Code: CAR-02400 Lot #: 13F19J0153 and 23F17H0547
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Mario Wijker; 353-90-6460865
• Manufacturer Reason for Recall: The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
• FDA Determined Cause: Incorrect or no expiration date
• Action: Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.
• Distribution: World wide 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 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 = NFK