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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet HL Console for Heart Lung Machine HL20

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 Class 2 Recall
Maquet HL Console for Heart Lung Machine HL20
see related information
Date Posted August 22, 2011
Recall Status1 Terminated on October 16, 2012
Recall Number Z-3057-2011
Recall Event ID 59576
Premarket Notification
510(K) Number
K943803 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751 The HL 20 is indicated for use as an extracorporeal circulation device for perfusion lasting not more then six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.
Code Information 510K numer K943803 Device Listing #E614811 HL-20 Console
Recalling Firm/
Manufacturer
Maquet Inc.
45 Barbour Pond Drive
Wayne, New Jersey 07470
For Additional Information Contact Ms. Susan mandy
201-995-8968
Manufacturer Reason
for Recall
HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Maquet sent an URGENT PRODUCT RECALL NOTIFICATION letter dated June 17, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to acknowledge receipt of the notification by completing and sending back the attached response form whether or not they have any affected product, fax to 973-807-9210 no later than June 30, 2011. For any questions customers were instructed to contact thier local MAQUET representative.
Quantity in Commerce 229 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = JANUS BIOMEDICAL, INC.
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