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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Medical

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  Class 2 Device Recall Fresenius Medical see related information
Date Initiated by Firm September 20, 2004
Date Posted October 13, 2004
Recall Status1 Terminated 3 on June 28, 2006
Recall Number Z-0017-05
Recall Event ID 30007
510(K)Number k822550  
Product Classification Set, Administration, For Peritoneal Dialysis, Disposable - Product Code KDJ
Product Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile
with Female Safe Lock Connector Luer Lock and Slide Clamp

Catalog Number: 050-30034
Code Information Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290
Recalling Firm/
Manufacturer		 Fresenius Medical Care North America
95 Hayden Ave
Lexington MA 02421-7942
For Additional Information Contact Arthur Ellinsfeld
781-402-9068
Manufacturer Reason
for Recall		 Peritoneal Dialysis Transfer Set may have occluded pathway
FDA Determined
Cause 2		 Other
Action Fresenius Medical is conducting telephone contact to the dialysis clinics starting 9/20/04 and follow-up with a notice to be mailed o/a 9/27/04.Clinics are requested to examine inventory for lot numbers and return unused product to Fresenius.
Quantity in Commerce 3,510 units
Distribution Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON
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 = KDJ and Original Applicant = AMERICAN MEDICAL PRODUCTS, INC.
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