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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 21, 2005
Date Posted April 29, 2006
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = HAEMONETICS CORP.
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