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-0287-2007
• Recall Event ID: 36522
• 510(K)Number: K882230 K921475
• Product Classification: Implantable Vascular Access System - Product Code LJT
• Product: Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref Product No. AP-01510
• Code Information: Product No. AP-01510. Lot Numbers: MF2061389, MF2071761, MF2082058, MF2122799,MF2122869, MF3013124, MF3023533, MF3033713, MF3044092, MF3044143, MF3054233, MF3054527,MF3064662, MF3064871, MF3085292, MF3085315, MF3095651, MF3116183, MF3116212, MF3126476, MF4016721, MF4020469, MF4020739, MF4105255, MF5017539, MF5081888, MF6068638, MS3110153,MS4041605, MS4041616, MS4041617,MS4041618.
• 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: 204
• 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