Class 2 Device Recall Arrow

• Date Initiated by Firm: September 29, 2006
• Date Posted: December 19, 2006
• Recall Status: Terminated on June 04, 2007
• Recall Number: Z-0274-2007
• Recall Event ID: 36522
• 510(K)Number: K790882 K911055
• Product Classification: Implantable Vascular Access System - Product Code LJT
• Product: Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port , 12 Fr. Introducer Kit. Ref Product Code: AP-06528
• Code Information: Product No. AP-06528. Lot Number: 12054, MF3033635, MF3075166, MF3095536, MF3105900, MF3116038, MF4016607, MF4020455, MF4020838, MF4063175, MF4073793, MF4084293, MF4084406, MF4105408, MF5017415, MF5049326, MF6014778, MF6068936, MF6079334.
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Paul Cornelison; 610-378-0131
• Manufacturer Reason for Recall: Catheter has separated from the infusion port body.
• FDA Determined Cause: Other
• Action: The recall notification was sent out to their US customers on 9/29/2006.
• Quantity in Commerce: 194
• Distribution: Nationwide. The firm is NOT recalling from international accounts.
• 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 = LJT; 510(K)s with Product Code = LJT