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Class 2 Device Recall Haemonetics cardioPAT System |
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Date Initiated by Firm |
October 15, 2007 |
Date Posted |
December 08, 2007 |
Recall Status1 |
Terminated 3 on March 19, 2012 |
Recall Number |
Z-0358-2008 |
Recall Event ID |
45427 |
510(K)Number |
K053000
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Product Classification |
Autotransfusion Apparatus (CAC) - Product Code CAC
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Product |
Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion) |
Code Information |
All Serial numbers |
Recalling Firm/ Manufacturer |
Haemonetics Corporation 400 Wood Rd Braintree MA 02184-2412
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For Additional Information Contact |
781-848-7100
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Manufacturer Reason for Recall |
Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest
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FDA Determined Cause 2 |
Labeling design |
Action |
Haemonetics issued a Labeling suppplement to users via a Field Notification letter on October 15, 2007. Users are provide additional Directions for use for the Operator's Guide and Quick Reference Guide. |
Quantity in Commerce |
106 units |
Distribution |
Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = CAC and Original Applicant = HAEMONETICS CORP.
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