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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-0823-06
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 Number: LN02005-110EP
Code Information Serial Numbers:  05F022-1; 05F023-1; 05H103;05C083-05C084; 05C087-05C089;05D006-05D011;05D037--05D040; 05D043-05D047;05D060-05D068;05D080--05D081; 05D085-05D089; 05E026-05E035;05E054-1; 05E055-1; 05E056;05E061-05E070; 05E091-05E095; 05F021; 05F066-05F072; 05F098-05F107;05F142-05F144; 05F147; 05F149; 05F150; 05F157-05F159;05G008-1; 05G009-05G012; 05G035-05G037; 05G038-1; 05G055-1; 05G057-05G059; 05G080-05G084;05H018; 05H022; 05H024- 05H027; 05H073-05H077; 05H100-05H101; 05H104; 05H163;  05J185-05J189; 05K011-05K013; 05K015--05K017; 05K092-05K096; 05K168-05K173 ; 05K175;  05K201
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 151 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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