Class 2 Device Recall Haemonetics cardioPAT System

• Date Initiated by Firm: October 15, 2007
• Date Posted: December 08, 2007
• Recall Status: Terminated on March 19, 2012
• Recall Number: Z-0358-2008
• Recall Event ID: 45427
• 510(K)Number: K053000
• Product Classification: Autotransfusion Apparatus (CAC) - Product Code CAC
• 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
• For Additional Information Contact: 781-848-7100
• 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
• FDA Determined Cause: 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

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 = CAC