Class 2 Device Recall MAC Two Lumen Central Venous Access

• Date Initiated by Firm: July 29, 2010
• Date Posted: September 25, 2010
• Recall Status: Terminated on July 05, 2012
• Recall Number: Z-2488-2010
• Recall Event ID: 56363
• 510(K)Number: K002507
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
• Code Information: Product # AK-11142-B, Lot # RF0033311
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Road; Reading PA 19605
• For Additional Information Contact: Christine Richards; 800-523-8446
• Manufacturer Reason for Recall: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
• FDA Determined Cause: Mixed-up of materials/components
• Action: The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
• Quantity in Commerce: 16
• Distribution: The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
• 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 = DYB