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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 Device Recall Maquet Heart Lung Machine HL20 see related information
Date Initiated by Firm September 28, 2010
Date Posted February 22, 2011
Recall Status1 Terminated 3 on August 11, 2011
Recall Number Z-1394-2011
Recall Event ID 57082
510(K)Number K943803  
Product Classification Heart Lung Machine - 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 NJ 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		 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 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 = DTQ and Original Applicant = JANUS BIOMEDICAL, INC.
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