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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Heart Lung Machine HL20

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 Class 2 Recall
Maquet Heart Lung Machine HL20
see related information
Date Posted February 22, 2011
Recall Status1 Terminated on August 11, 2011
Recall Number Z-1394-2011
Recall Event ID 57082
Premarket Notification
510(K) Number
K943803 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
Code Information Device Part Number (Model Number): 703309 Serial Numbers: 93202512, 93202514, 93202526, 93202527
Recalling Firm/
Manufacturer
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne, New Jersey 07470
Manufacturer Reason
for Recall
A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Maquet hand delivered a letter to the consignee on 10/4/2010.
Quantity in Commerce 4 units
Distribution One hospital in New York City
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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