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U.S. Department of Health and Human Services

Class 2 Device Recall Jostra Heater Cooler

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 Class 2 Device Recall Jostra Heater Coolersee related information
Date Initiated by FirmNovember 10, 2006
Date PostedJanuary 25, 2007
Recall Status1 Terminated 3 on February 05, 2007
Recall NumberZ-0350-2007
Recall Event ID 37023
510(K)NumberK031544 
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
ProductJostra 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 ContactJamie 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 2		Other
ActionLetters were mailed to customers on 11/10/2006 by Federal Express.
Quantity in Commerce13 units
DistributionHospitals in CA, NC, FL, WY, NY and WV.S
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWC
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