Class 2 Device Recall ARROW Pressure Injectable Arrowgard Blue Advance Midline Kit

• Date Initiated by Firm: September 14, 2022
• Date Posted: October 19, 2022
• Recall Status: Terminated on January 19, 2024
• Recall Number: Z-0102-2023
• Recall Event ID: 90871
• 510(K)Number: K161313
• Product Classification: Midline catheter - Product Code PND
• Product: ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
• Code Information: UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757
• 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: Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).
• FDA Determined Cause: Under Investigation by firm
• Action: The firm sent an URGENT MEDICAL DEVICE NOTFICATION to its sole consignee on 09/15/2022, by FedEx 2-day mail. The letter explained the reason for recall and requested the following: "Please adhere to the following actions: 1. Check your inventory for products in scope of this advisory notice. 2. If you do not have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 2) and return the form to Teleflex Customer Service using the contact information below. 3. If you have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 2), return the form to Teleflex Customer Service using the contact information below, and place a copy of this advisory notice with all affected products. Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service using the contact information below or may also be reported to the FDA s MedWatch Adverse Event Reporting program either by phone at 1-888-INFO-FDA (1-888-463-6332) or online at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverseevent-reporting-program. Transmission of this Advisory Notice This advisory notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please consider end users, clinicians, risk managers, supply chain/distribution centres, etc., in the circulation of this notice. Please maintain awareness of this notice until all required actions have been completed in your organization.
• Quantity in Commerce: 18 devices
• Distribution: US Nationwide distribution in the state of Florida.
• 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 = PND and Original Applicant = ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)