Class 2 Device Recall

• Date Initiated by Firm: December 21, 2005
• Date Posted: April 29, 2006
• Recall Status: Terminated on March 12, 2008
• Recall Number: Z-0822-06
• Recall Event ID: 34372
• 510(K)Number: K014083
• Product Classification: Apparatus, Autotransfusion - Product Code CAC
• Product: Haemonetics Cell Saver 5 Autogolous Blood Recovery System Model Numbr: LN02005-110-E
• Code Information: Serial Numbers: 94H180CD-1; 95A048CS; 95J177CS
• FEI Number: 1219343
• Recalling Firm/ Manufacturer: Haemonetics Corporation; 400 Wood Rd; Braintree MA 02184-2412
• For Additional Information Contact: JohnSokolowski; 781-356-9488
• Manufacturer Reason for Recall: Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard
• FDA Determined Cause: Other
• Action: Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD .
• Quantity in Commerce: 3 units
• Distribution: Nationwide
• 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