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U.S. Department of Health and Human Services

Class 2 Device Recall Haemonetics cardioPAT

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 Class 2 Recall
Haemonetics cardioPAT
see related information
Date Posted February 22, 2011
Recall Status1 Terminated on January 14, 2013
Recall Number Z-1391-2011
Recall Event ID 57805
Premarket Notification
510(K) Number
K053000 
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
Code Information All serial numbers
Recalling Firm/
Manufacturer
Haemonetics Corporation
400 Wood Road
Braintree, Massachusetts 02184-2412
Manufacturer Reason
for Recall
Update Instructions for Use for the CardioPAT® Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could result in the patient experiencing a pneumothorax.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Haemonetics issued a Field Correction Notice on 1/25/11 . with the Air Leak Detection addendum and index be inserted into the appropriate document, applied to all cardioPAT@ devices on site. The serial number for each cardioPAT device on site should be recorded on the attached acknowledgement and the completed acknowledgement should be returned to your Haemonetics Sales Consultant. A Haemonetics Sales Consultant will train on the content of these items and insert them into the Operator Manuals.
Quantity in Commerce 309 units
Distribution Worldwide distribution, including USA, Australia, Belgium, Canada, Switzerland, China, Germany, Finland, France, United Kingdom, Hong Kong, Israel, Italy, Japan, Netherlands, Russian Federation, and Sweden.
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 = CAC and Original Applicant = HAEMONETICS CORP.
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