Class 2 Device Recall Arrow Arterial Catherization Kit

• Date Initiated by Firm: December 12, 2019
• Create Date: January 23, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0844-2020
• Recall Event ID: 84635
• 510(K)Number: K810675
• Product Classification: Wire, guide, catheter - Product Code DQX
• Product: Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.
• Code Information: Lot/Batch Number: PMC 23F19H0224
• FEI Number: 3015859709
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: SAME; 610-378-0131
• Manufacturer Reason for Recall: The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
• FDA Determined Cause: Labeling Change Control
• Action: Arrow International issued an " Urgent Medical Device Recall Notice" to its US consignee on 12th Dec 2019 via FedEx 2-day mail. The letter states reason for recall, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Questions contact your local sales representative or Customer Service at 1-866-396-2111.
• Quantity in Commerce: 80 eaches
• Distribution: US distribution to SC
• 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 = DQX