Class 2 Device Recall Jostra Heater Cooler

• Date Initiated by Firm: November 10, 2006
• Date Posted: January 25, 2007
• Recall Status: Terminated on February 05, 2007
• Recall Number: Z-0350-2007
• Recall Event ID: 37023
• 510(K)Number: K031544
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
• Code Information: Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.
• Recalling Firm/ Manufacturer: MAQUET Inc.; 1140 US Highway 22; Bridgewater NJ 08807-2958
• For Additional Information Contact: Jamie Yieh; 908-947-2311
• Manufacturer Reason for Recall: The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.
• FDA Determined Cause: Other
• Action: Letters were mailed to customers on 11/10/2006 by Federal Express.
• Quantity in Commerce: 13 units
• Distribution: Hospitals in CA, NC, FL, WY, NY and WV.S
• 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 = DWC and Original Applicant = JOSTRA AB