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U.S. Department of Health and Human Services

Class 3 Device Recall Disposable Set for autologous blood cell recovery

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  Class 3 Device Recall Disposable Set for autologous blood cell recovery see related information
Date Initiated by Firm December 17, 2002
Date Posted January 30, 2003
Recall Status1 Terminated 3 on January 28, 2016
Recall Number Z-0502-03
Recall Event ID 25342
510(K)Number K932890  
Product Classification Disposable Set for autologous blood cell recovery - Product Code CAC
Product Haemonetics Cell Saver 5 Low Volume (125mL) Fast Pack
List Number: 265
Code Information KK02003 KK02011 KK02012 KK02014 KK02020 KK02100 LL02001 LL02009 LL02015 LL02022 
Recalling Firm/
Manufacturer		 Haemonetics Corporation
400 Wood Road
Braintree MA 02184
For Additional Information Contact Lisa Lopez
781-848-7100
Manufacturer Reason
for Recall		 Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
FDA Determined
Cause 2		 Other
Action Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.
Quantity in Commerce 2430
Distribution Nationwide Canada
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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