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-0279-2007
• Recall Event ID: 36522
• 510(K)Number: K790882 K934792
• Product Classification: Implantable Vascular Access System - Product Code LJT
• Product: Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 6 Fr. Introducer Kit Ref. Product No. AP-06036
• Code Information: Product No. AP-06036. Lot Numbers: MF2081824, MF2092267, MF3013206, MF3023468, MF3033568, MF3043935, MF3054360, MF3054525, MF3126300, MF4016726, MF4031047, MF4042099, MF4062964, MF4105288, MF4105802, MF4126773, MF5027944, MF5038765, MF5070950, MF5124151, MF6014960, MF6036562, MF6047448, MF6058105, MF6058348, MF6036931, MF6068655.
• 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: 125
• 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