Class 1 Device Recall Arrow MAC TwoLumen Central Venous Access Kit

• Date Initiated by Firm: October 27, 2022
• Date Posted: December 10, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0351-2023
• Recall Event ID: 91090
• 510(K)Number: K002507 K071538
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
• Code Information: UDI/DI 10801902159448, Lot Number 13F22C0349
• Recalling Firm/ Manufacturer: ARROW INTERNATIONAL Inc.; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• For Additional Information Contact: Customer Service; 866-396-2111
• Manufacturer Reason for Recall: There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.
• FDA Determined Cause: Process control
• Action: The firm issued an "URGENT MEDICAL DEVICE RECALL" to its consignees on 10/27/2022 by FedEx 2-day mail. The notice explained the problem, the risk, and requested the following: "Action list number 1 Medical facilities 1. Immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have affected product, complete the RECALL ACKNOWLEDGEMENT FORM, Contact Teleflex Customer Service to receive a return goods authorization (RGA) number. 3. Complete and return form even if you do not have affected product. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Action list number 2 Distributors 1. Provide this recall notice to all customers who have received affected product. Each customer is then required to complete the Acknowledgement Form (Appendix 1) and return it to you. 2. Immediately check your inventory for affected product. Cease use and distribution of affected product and immediately quarantine the affected product. You may then return all product in scope. 3. Confirm to Teleflex that you have completed the field activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of your actions, please forward the completed Acknowledgement Form to Teleflex Customer Service at the contact details provided below. Important - Please ensure you only list lot numbers in scope of this recall notice when completing the Acknowledgement Form (Appendix 1). 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by return email to the email address provided below. Customer Service via Email: Recalls@teleflex.com, Customer Service Telephone: 1-866-396-2111, or FAX: 1-855-419-8507. Customer Service hours of operation are 8am-7pm EST.
• Quantity in Commerce: 80 units
• Distribution: US Distributor in states of: FL, GA, KY, OH, PA and WV.
• 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.

• 510(K) Database: 510(K)s with Product Code = FOZ and Original Applicant = ARROW INTERNATIONAL, INC.; 510(K)s with Product Code = FOZ and Original Applicant = ARROW INTL., INC.