Class 2 Device Recall Arrow PICC

• Date Initiated by Firm: April 23, 2019
• Create Date: June 16, 2019
• Recall Status: Terminated on January 13, 2021
• Recall Number: Z-1788-2019
• Recall Event ID: 82865
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: Arrow PICC Kit Product Code: ASK 45541 LVH1
• Code Information: Batch Code: 23F18E0221
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: 610-378-0131
• Manufacturer Reason for Recall: Lidstock states the incorrect expiration date for the product
• FDA Determined Cause: Process control
• Action: Arrow International initiated recall by letter dated April 23,2019 described the problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Complete the enclosed Acknowledgement Form 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. Distributors requested to subrecall. Questions, contact your local sales representative or Customer Service at 1-866-396-2111.
• Quantity in Commerce: 105 units
• Distribution: Nationwide Foreign:
• 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.