Class 2 Device Recall Maquet HLM Tubing Pack

• Date Initiated by Firm: July 13, 2010
• Date Posted: September 12, 2010
• Recall Status: Terminated on August 10, 2011
• Recall Number: Z-2401-2010
• Recall Event ID: 56268
• 510(K)Number: K053025
• Product Classification: Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
• Product: Maquet HLM Tubing Pack; Bioline Coating
• Code Information: Product number BEQ-TOP 14801; lot numbers 70040244, 70046759.
• Recalling Firm/ Manufacturer: Maquet Inc.; 45 Barbour Pond Drive; Wayne NJ 07470
• For Additional Information Contact: Whiting Torning; 973-709-9774
• Manufacturer Reason for Recall: The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.
• FDA Determined Cause: Process control
• Action: Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.
• Quantity in Commerce: 5 units
• Distribution: Distribution: Pennsylvania
• 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 = DWE and Original Applicant = MAQUET CARDIOPULMONARY AG