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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Medical Care

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  Class 2 Device Recall Fresenius Medical Care see related information
Date Initiated by Firm March 22, 2006
Date Posted May 03, 2006
Recall Status1 Terminated 3 on July 11, 2006
Recall Number Z-0834-06
Recall Event ID 35184
510(K)Number K002892  
Product Classification System, Peritoneal, Automatic Delivery - Product Code FKX
Product Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis.
Catalog Number: 050-87028
Code Information Lot Numbers: 5SR119; 52R124; 5SR125; 5SR149; 5SR150; 5SR173; 6AR014; 6AR015; 6AR032; 6AR044; 6AR045; 6AR055; 6AR069; 6AR085; 06AR086; 6AR267; 6AR280;6AR298; 6BR013;6BR031; 6BR040; 6BR043; 6BR064; 6BR075; 6BR091; 6BR092; 6BR110; 6BR127; 6BR141; 6BR281 
Recalling Firm/
Manufacturer		 Fresenius Medical Care North America
95 Hayden Avenue
Lexington MA 02421-7942
For Additional Information Contact Arthur E. Eilinsfeld
781-402-9009
Manufacturer Reason
for Recall		 Stay safe trigger body may not connect to the extension set and result in associated peritonitis
FDA Determined
Cause 2		 Other
Action Fresenius Medical notified customers by telephone on 3/24/06 for initial lots recalled and followed by letter dated 3/30/06 to include all lots numbers recalled.
Quantity in Commerce 141,770 units
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 = FKX and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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