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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-0501-03
Recall Event ID 25342
510(K)Number K932890  
Product Classification Disposable Set for autologous blood cell recovery - Product Code CAC
Product Haemonetics High Speed Cell Saver Bowl Set
List Number: 263
Code Information J02115 J02131 J02142 J02150 J02162 G02081 G02086 G02092 G02103 G02133 G02141 H02007 H02015 H02024 H02038 H02102 H02108 H02120 H02147 H02157 H02165 H02239 H02249 J02032 J02040 J02049 J02058 J02061 J02076 J02172 J02194 J02208 K02015 K02027 K02037 K02045 K02056 K02066 K02139 K02161 K02171 K02208 K02217 K02224 K02236 L02002 L02049 L02059 L02093 L02103 L02113 L02144 L02163 L02199 M02002 M02010 M02014 M02022 M02027 M02035 
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 11302
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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