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-0285-2007
• Recall Event ID: 36522
• 510(K)Number: K921379 K926011
• Product Classification: Implantable Vascular Access System - Product Code LJT
• Product: Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014
• Code Information: Product No. AP-06014. Lot Numbers: 12130, 12134, MF3074955, MF3075069, MF3116186,MF3116232, MF3126390, MF4020623, MF4073774, MF4094578, MF4094703, MF4126653, MF5049105,MF5050037, MF5092675, MF5103680, MF6014995, MF6079156, MF6089978.
• FEI Number: 3015859709
• 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: 94
• 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