Class 2 Device Recall Arrow Endurance Catheter System

• Date Initiated by Firm: December 06, 2019
• Create Date: January 22, 2020
• Recall Status: Terminated on November 02, 2021
• Recall Number: Z-0837-2020
• Recall Event ID: 84520
• 510(K)Number: K163513
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
• Code Information: REF: ASK-00820-FLH Manufacturing Lots: 13F19E0247, 13F19F0006, and 13F19G0433 Exp. Date: Aug. 2020 - Sep. 2020
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: 610-378-0131
• Manufacturer Reason for Recall: Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.
• FDA Determined Cause: Employee error
• Action: On December 6, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: Urgent Medical Device Recall Notice Arrow Endurance" Extended Dwell Peripheral Catheter System EIF-000391 December 06, 2019 To: Customer of Arrow Products Arrow International is voluntarily recalling the following product code and lots: Product Code: ASK-00820-FLH Lot Numbers: 13F19E0247, 13F19F0006, 13F19G0433 Arrow International is recalling the above product code and lots due to a potential sterility issue. The product was processed through the incorrect sterilization cycle; thus, the sterility of the device cannot be guaranteed. If the devices sterility is compromised and the product is used it could lead to infectious complications. No complaints, patient injuries or deaths have been reported at this time. Our records indicate you have received products that are subject to this action. We are now notifying our customers to take the following actions: 1. Inspect your inventory for the affected product codes above. If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. Adverse reactions or quality problems experienced with the us
• Quantity in Commerce: 575
• Distribution: US: FL
• 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 = FOZ and Original Applicant = Arrow International, Inc. (subsidiary of Teleflex Inc.)